QuickVue® RSV Test
Quidel Corporation Page 1 of 8
Catalog No.: 20193 / 20199
Reference No.: K061008 Revision Date: September 20, 2006
SECTION 1 – Kit / Preparation and Company Identification
1.1 QUICKVUE RSV TEST For in-vitro diagnostic use only
1.2 The QuickVue RSV test is intended for use as an aid in the rapid diagnosis of acute respiratory syncytial viral
infections.
1.3 Manufacturer: Quidel Corporation – 10165 McKellar Court – San Diego, CA 92121
Telephone No.: 1-858-552-1100 Toll Free No.: 1-800-874-1517 Fax No.: 1-858-453-4338
1.4 Emergency No.: Poison Control @ 1-800-876-4766 (United States only)
SECTION 2 – Composition / Ingredients Information
2.1 Description of Components: Test strips, Extraction Reagent with detergents, Extraction Tubes,
Disposable Droppers, Nasopharyngeal Swabs, Positive RSV Control Swab,
and Negative Control Swab.
2.2 Hazardous Ingredients: Dangerous solid or liquid substances present in >1% (or as required by applicable
U.S., Canadian and E.U. regulations): The classifications listed below are based on the 0.2% sodium azide
concentration.
Classification:
CAS# EINECS
Chemical
Name
Kit
Component
%
Weight US OSHA WHMIS EU Risk Phrases
26628-22-8 247-852-1 Sodium Azide RSV Extraction
Reagent 0.2% Irritant N/A Xn R25, R32, R52
The RSV Extraction Reagent preparation is not classified as hazardous under U.S. OSHA 29 CFR
1910.1200; E.C. Directive 1999/45/EC; or the Canadian Hazardous Products Act, R.S. 1985, c. H-3.
SECTION 3 – Hazard Identification
Emergency Overview: As part of good industrial and personal hygiene and safety procedure, avoid all
unnecessary exposure to the chemical components within this kit and ensure prompt
removal from skin, eyes, and clothing.
3.1 Significant health effects are NOT anticipated from routine use of this kit when adhering to the instructions
listed in the Package Insert provided with the kit.
3.2 Contact with the RSV Extraction Reagent to the eyes and/or skin may cause slight irritation upon prolonged
exposure. Avoid prolonged contact with any chemical component within this kit.
3.3 This kit may contain material of human or animal origin and should be considered as potentially capable of
transmitting infectious diseases.
3.4 All patient samples should be handled as potentially infectious. Follow Universal Precautions as necessary.
3.5 Warning Properties: None
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Quidel Corporation Page 2 of 8
SECTION 4 – First Aid Measures
Special Instructions: No special measures are required.
4.1 Inhalation Inhalation of any component in this kit is unlikely.
4.2 Eye Contact Extraction Reagent may cause slight irritation upon contact. In case of contact with eyes,
immediately wash eyes under potable running water for at least 15 minutes, making sure that
the eyelids are held open. If pain or irritation occurs, obtain medical attention.
4.3 Skin Contact RSV Extraction Reagent may cause slight irritation upon contact. Remove any contaminated
clothing and wash affected area with plenty of soap and water. If pain or irritation occurs,
obtain medical attention.
4.4 Ingestion If RSV Extraction Reagent is swallowed, wash mouth out with water provided person is
conscious. If irritation or discomfort occurs, obtain medical attention.
SECTION 5 – Fire Fighting Measures
5.1 Flammable Properties: RSV Extraction Reagent is non-flammable.
5.2 Extinguishing Media: For small fires, use dry chemical, carbon dioxide, or alcohol-resistant foam.
5.3 Special Fire Fighting Procedures: This material will not significantly contribute to the intensity of a fire. Use
extinguishing material suitable to the surrounding fire. Utilize proper personal protective equipment when
responding to any fire. Incipient fire responders should wear eye protection. Structural firefighters must wear
Self-Contained Breathing Apparatus and full protective equipment. Move containers from fire area if it can be
done without risk to personnel. If possible, prevent runoff water from entering storm drains, bodies of water, or
other environmentally sensitive areas.
5.4 Unusual Fire and Explosion Hazards: When involved in a fire, this material can decompose and produce
irritating fumes and toxic gases (e.g., Carbon monoxide, Carbon dioxide).
Explosion Sensitivity to Mechanical Impact: Not sensitive under normal conditions.
Explosion Sensitivity to Static Discharge: Not sensitive under normal conditions.
5.5 Additional Considerations (Extraction Reagent):
5.5.1 Flash Point Non Combustible
5.5.2 Auto-ignition Temperature Not Applicable
5.5.3 Upper / Lower Explosion Limit Not Applicable
5.6 NFPA Ratings (see Section 16 for definitions of numerical ratings):
RSV Extraction Reagent
** Only trained and competent personnel shall
attempt to extinguish a fire. Contact emergency
response personnel as required. Be cautious of
surrounding materials that may react with the
extinguishing media. 0
0
0
Healltth Reacttiiviitty
Reference only
Fllammabiilliitty
Otther Hazards
QuickVue® RSV Test
Quidel Corporation Page 3 of 8
SECTION 6 – Accidental Release Measures
6.1 Personal Precautions: Wear Personal Protective Equipment (PPE) as indicated in Section 8. Avoid
physical contact with the RSV Extraction Reagent. Wash hands thoroughly
after handling the components within this kit or patient samples. This kit
contains materials of biological origin. Avoid personal contact. Use Universal
Precautions when performing the test and during the clean-up process.
6.2 Environmental Precautions: This preparation contains a small amount of sodium azide which can react
with copper, lead, brass or solder in plumbing systems and form potentially
explosive metal azides. If preparation enters the drain, flush with a large
volume of water to prevent azide build-up. Contain spills to prevent migration
to industrial or sanitary sewer drains.
6.3 Spill and Leak Procedures: Large spills of this kit are unlikely. Personnel who have received basic
chemical safety training can generally handle small-scale releases, such as
1 container of this kit. Utilize safety glasses, nitrile gloves, and lab
coat/apron when responding to spills involving the components of this kit.
Absorb liquid and place in container suitable for disposal. Dispose of in
accordance with applicable U.S. Federal, State, or local procedures or
appropriate standards of Canada or the EU (see Section 13, Disposal
Considerations).
SECTION 7 – Handling and Storage
7.1 Handling: As with all chemicals, avoid getting components within this kit ON YOU or IN YOU. Wash
exposed areas thoroughly after using this kit. Do not eat or drink while using this kit. This kit
should be handled only by qualified clinical or laboratory employees trained on the use of this
kit and who are familiar with the potential hazards. This kit should be handled as though
capable of transmitting infectious diseases. Universal Precautions should be followed when
using this kit. Not for use by the general public.
7.2 Storage: Keep away from incompatible materials (Section 10). To maintain efficacy, store according to
the package insert instructions.
7.3 Specific Use: For in-vitro diagnostic use only
SECTION 8 – Exposure Controls and Personal Protection
8.1 Exposure Limits: There are no ACGIH, NIOSH, OSHA or country specific occupational exposure limits
currently established for components present in this preparation at concentrations equal
to or greater than 1% (0.1% if carcinogen).
8.2 Occupational Exposure Controls:
8.2.1 Engineering Controls:
The RSV Extraction Reagent is aqueous and non-volatile and is not expected to necessitate special
ventilation measures. Facilities storing or utilizing this reagent should be equipped with an eyewash
fountain and a safety shower.
8.2.2 Personal Protective Equipment (PPE):
Respiratory: None needed under normal conditions of use.
Eye Contact: Safety glasses or face shield are recommended to prevent eye contact.
Hand Contact: Impervious gloves (nitrile or equivalent) should be worn to prevent hand contact.
Skin Contact: Lab Coat or similar long sleeved garment should be worn to prevent exposure to
skin and contamination of clothing.
QuickVue® RSV Test
Quidel Corporation Page 4 of 8
SECTION 9 – Physical and Chemical Properties
Characteristic RSV Extraction Reagent
Boiling Point (°C) Not Available
Melting Point (°C) Not available
Specific Gravity Approximately 1
Vapor Pressure (mm Hg) Not available
Vapor Density (AIR = 1) Not available
Evaporation Rate (Ether = 1) < 1
pH: Neutral
Solubility in Water: Soluble
Appearance and Odor: Clear, Odorless
SECTION 10 – Stability and Reactivity
Characteristic RSV Extraction Reagent
Stability Stable
Conditions to Avoid Incompatible materials
Materials to avoid
(Incompatibilities) None Known
Hazardous Decomposition or Byproducts Nature of decomposition of products not known
Hazardous Polymerization Will not occur
SECTION 11 – Toxicological Information
11.1 Toxicity Data for Hazardous Ingredients: There are currently no toxicity data available for the components
of this kit; the following toxicology information is available for raw materials present in greater than 1%
concentration.
RSV Extraction Reagent:
When used and handled according to specifications, this product does not have any harmful effects
according to our experience. The substance is not subject to classification.
11.2 Routes of Exposure:
Overexposures to components within this kit are not expected. Common routes of exposure may
include ingestion and eye/skin contact. Specific paths of concern for potentially infectious materials are skin
puncture, contact with broken skin, contact with mucous membranes and inhalation of aerosolized material.
11.3 Potential Effects of Acute Overexposure, By Route Of Exposure:
This kit may contain materials of human or animal origin and should be considered as potentially capable of
transmitting infectious diseases.
INHALATION: No irritating effect known
CONTACT WITH SKIN or EYES: No irritating effect known
SKIN ABSORPTION: No irritating effect known
INGESTION: No irritating effect known
INJECTION: No irritating effect known
QuickVue® RSV Test
Quidel Corporation Page 5 of 8
11.4 Potential Effects of Chronic Exposure:
Long-term skin or eye contact may result in dermatitis or eye irritation.
11.5 Symptoms of Overexposure:
Symptoms of overexposure to the RSV Extraction Reagent may include general eye, skin, nose, and throat
irritation.
To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly
investigated for the contents within this kit.
11.6 Medical Exposure Aggravated by Exposure:
Persons with pre-existing skin disorders, eye problems or impaired respiratory system function can be more
susceptible to health effects associated with overexposures to the chemicals within this kit.
11.7 Carcinogenicity: None of the components present in the RSV Extraction Reagent preparation at
concentrations equal to or greater than 0.1% are listed by IARC, ACGIH, NTP, OSHA or California Prop 65.
CHEMICAL NAME ACGIH IARC NTP OSHA
N/A N/A N/A N/A N/A
SECTION 12 – Ecological Information
12.1 Ecotoxicity – Not Available
No adverse effects on the environment are expected from the components of this kit.
12.2 Mobility, Persistence and Degradability
Mobility, persistence and degradation data are not available for the components of this kit.
12.3 Bioaccumulative Potential
There is limited potential for the components within this kit to accumulate in plant or animal systems. The
ecological effects have not been thoroughly investigated, but currently none have been identified.
SECTION 13 – Disposal Considerations
Dispose of waste materials, unused components and contaminated packaging in compliance with country (i.e.,
Canada, EU) federal, state and local regulations. If unsure of the applicable requirements, contact the authorities
for information. This product is not considered a RCRA hazardous waste.
RCRA P-Series: P105, Sodium Azide
RCRA U-Series: None listed
SECTION 14 – Transport Information
14.1 U.S. Transportation
This product is regulated per 49 CFR 172.101, the U.S. department of transportation:
Proper Shipping Name: None
Non-Hazardous for Transport: This substance is considered to be non-hazardous for transport.
14.2 Canadian Transportation
The above-listed DOT basic description applies to this product under the regulations of Transport Canada.
QuickVue® RSV Test
Quidel Corporation Page 6 of 8
14.3 International Air Transportation
This product is regulated per International Air Transportation Association (IATA) Dangerous Goods
Regulations:
Proper Shipping Name: None
Non-Hazardous for Transport: This substance is considered to be non-hazardous for air transport.
SECTION 15 – Regulatory Information
15.1 U.S. Federal and State Regulations:
This preparation is a component of an FDA-regulated in vitro diagnostic device.
Regulatory Reference RSV Extraction Reagent
40 CFR 355.30/355.40 - SECTION 302 Not applicable
40 CFR 302.4 – SECTION 304 Not applicable
40 CFR 372.65 – SECTION 313 Not applicable
U.S. SARA SECTION 311/312 FOR KIT: Acute health effects; chronic health effects.
U.S. TSCA INVENTORY STATUS: The components of this kit are listed on the TSCA Inventory.
OTHER U.S. FEDERAL REGULATIONS: Not applicable.
CALIFORNIA SAFE DRINKING WATER AND TOXIC ENFORCEMENT ACT (PROPOSITION 65): No
15.2 Label Information
ANSI 129.1 CAUTION: Harmful if swallowed, eye and skin irritant. Do not swallow or take internally. Do not
get into eyes, on skin, or on clothing.
ENVIRONMENTAL HAZARDS:
Do not discharge effluent containing this kit into streams, ponds, estuaries, oceans or other waters unless in
accordance with the requirements of a National Pollutant Discharge Elimination System (NPDES) permit and
the permitting authority has been notified in writing prior to discharge. Do not discharge effluent containing this
kit to sewer systems without previously notifying the local sewage treatment plant authority. For guidance,
contact your State Water Board or Regional Office of the EPA.
15.3 Canadian Regulations:
CANADIAN DSL/NDSL INVENTORY STATUS:
Sodium Azide is listed on the DSL Inventory.
CANADIAN WHMIS SYMBOLS:
None Required
15.4 HMIS Ratings (See Page 8 for Definition of Ratings):
RSV Extraction Reagent
Health 1 *
Flammability 0
Physical Hazard 0
Protective Equipment B
B: Safety glasses and gloves
Reference Only
QuickVue® RSV Test
Quidel Corporation Page 7 of 8
15.5 EU Labeling Classification:
RSV Extraction Reagent (0.2% Sodium Azide)
Classification:
Xn
Harmful
Risk Phrases:
R25: Toxic if swallowed
R32: Contact with acids liberates very toxic gas
R52: Harmful to aquatic organisms
Safety Phrases:
S23: Do not breathe vapor
S24/25: Avoid contact with skin and eyes.
S29/35: Do not empty into drains; dispose of this material and its
container in a safe way.
***EU Classification, Risk Phrases and Safety Phrases are based on the chemical characteristics for Sodium Azide. The RSV Extraction
Reagent is not classified as a hazardous material.
SECTION 16 – Other Information
PREPARED BY: Quidel Corporation
10165 McKellar Court
San Diego, CA 92121
1-800-874-1517
DATE OF PRINTING September 21, 2006
Quidel Corporation provides the information contained herein in good faith but makes no representation as to its
comprehensiveness or accuracy. This document is intended only as a guide to the appropriate precautionary
handling of the materials contained in this kit by a properly trained person using this kit. Quidel Corporation
shall not be held liable for any damage resulting from handling or use.
QuickVue® RSV Test
Quidel Corporation Page 8 of 8
DEFINITIONS OF TERMS
A large number of abbreviations and acronyms appear on a MSDS. Some of these, which are commonly used, include the following:
CAS #: This is the Chemical Abstract Service Number that uniquely
identifies each compound.
ACGIH - American Conference of Governmental Industrial
Hygienists, a professional association that establishes exposure
limits.
TLV - Threshold Limit Value - an airborne concentration of a
substance that represents conditions under which it is generally
believed that nearly all workers can be repeatedly exposed without
adverse effect. The duration must be considered, including the 8-
hour Time Weighted Average (TWA), the 15-minute Short Term
Exposure Limit, and the instantaneous Ceiling Level (C). Skin
absorption effects must also be considered.
OSHA - U.S. Occupational Safety and Health Administration
PEL - Permissible Exposure Limit - This exposure value means
exactly the same as a TLV, except that it is enforceable by OSHA.
The OSHA Permissible Exposure Limits are based in the 1989 PELs
and the June, 1993 Air Contaminants Rule (Federal Register: 58:
35338-35351 and 58: 40191). Both the current PELs and the
vacated PELs are indicated. The phrase, “Vacated 1989 PEL,” is
placed next to the PEL that was vacated by Court Order.
IDLH - Immediately Dangerous to Life and Health - This level
represents a concentration from which one can escape within 30-
minutes without suffering escape-preventing or permanent injury.
The DFG - MAK is the Republic of Germany’s Maximum Exposure
Level, similar to the U.S. PEL. NIOSH is the National Institute of
Occupational Safety and Health, which is the research arm of the
U.S. Occupational Safety and Health Administration (OSHA).
NIOSH issues exposure guidelines called Recommended Exposure
Levels (RELs). When no exposure guidelines are established, an
entry of NE is made for reference.
HAZARD RATINGS:
HAZARDOUS MATERIALS IDENTIFICATION SYSTEM: Health
Hazard: 0 (minimal acute or chronic exposure hazard); 1 (slight
acute or chronic exposure hazard); 2 (moderate acute or significant
chronic exposure hazard); 3 (severe acute exposure hazard;
onetime overexposure can cause permanent injury and can be fatal);
4 (extreme acute exposure hazard; onetime overexposure can be
fatal). * Indicates chronic hazard. Flammability Hazard: 0 (minimal
hazard); 1 (materials that require substantial pre-heating before
burning); 2 (combustible liquid or solids; liquids with a flash point of
38-93°C [100-200°F]); 3 (Class IB and IC flammable liquids with
flash points below 38°C [100°F]); 4 (Class IA flammable liquids with
flash points below 23°C [73°F] and boiling points below 38°C [100°
F]. Reactivity (Physical) Hazard: 0 (normally stable); 1 (material that
can become unstable at elevated temperatures or which can react
slightly with water); 2 (materials that are unstable but do not detonate
or which can react violently with water); 3 (materials that can
detonate when initiated or which can react explosively with water); 4
(materials that can detonate at normal temperatures or pressures).
NATIONAL FIRE PROTECTION ASSOCIATION: Health Hazard: 0
(material that on exposure under fire conditions would offer no
hazard beyond that of ordinary combustible materials); 1 (materials
that on exposure under fire conditions could cause irritation or minor
residual injury); 2 (materials that on intense or continued exposure
under fire conditions could cause temporary incapacitation or
possible residual injury); 3 (materials that can on short exposure
could cause serious temporary or residual injury); 4 (materials that
under very short exposure could cause death or major residual
injury). Flammability Hazard and Reactivity Hazard: Refer to
definitions for “Hazardous Materials Identification System”.
FLAMMABILITY LIMITS IN AIR:
Much of the information related to fire and explosion is derived from
the National Fire Protection Association (NFPA). Flash Point -
Minimum temperature at which a liquid gives off sufficient vapors to
form an ignitable mixture with air. Autoignition Temperature: The
minimum temperature required to initiate combustion in air with no
other source of ignition. LEL - the lowest percent of vapor in air, by
volume, that will explode or ignite in the presence of an ignition
source. UEL - the highest percent of vapor in air, by volume, that will
explode or ignite in the presence of an ignition source.
TOXICOLOGICAL INFORMATION:
Possible health hazards as derived from human data, animal
studies, or from the results of studies with similar compounds are
presented. Definitions of some terms used in this section are: LD50 -
Lethal Dose (solids & liquids) which kills 50% of the exposed
animals; LC50 - Lethal Concentration (gases) which kills 50% of the
exposed animals; ppm concentration expressed in parts of material
per million parts of air or water; mg/m3 concentration expressed in
weight of substance per volume of air; mg/kg quantity of material, by
weight, administered to a test subject, based on their body weight in
kg. Other measures of toxicity include TDLo, the lowest dose to
cause a symptom and TCLo the lowest concentration to cause a
symptom; TDo, LDLo, LDo, TC, TCo, LCLo, and LCo, the lowest
dose (or concentration) to cause lethal or toxic effects. BEI -
Biological Exposure Indices, represent the levels of determinants
that are most likely to be observed in specimens collected from a
healthy worker who has been exposed to chemicals to the same
extent as a worker with inhalation exposure to the TLV. Ecological
Information: EC is the effect concentration in water.
Data from several sources are used to evaluate the cancer-causing
potential of the material. The sources and ratings are: IARC - the
International Agency for Research on Cancer; 1 = Carcinogenic to
humans, 2A, 2B = Probably carcinogenic to humans, 3 =
Unclassifiable as to carcinogenicity in humans, and 4 = Probably not
carcinogenic to humans. NTP - the National Toxicology Program; K
=Known to be a human carcinogen, and R = Reasonably anticipated
to be a human carcinogen. RTECS - the Registry of Toxic Effects of
Chemical Substances. OSHA - Occupational Safety and Health
Administration and CAL/OSHA - California’s subunit of the
Occupational Safety and Health Administration; Ca = Carcinogen
defined with no further categorization. ACGIH – American
Conference of Governmental Industrial Hygienists; A1 = Confirmed
human carcinogen, A2 = Suspected human carcinogen, A3 =
Confirmed animal carcinogen with unknown relevance to humans,
A4 = Not classifiable as a human carcinogen, and A5 = Not
suspected as a human carcinogen. NIOSH – U.S. National Institute
for Occupational Safety and Health; Ca = Potential occupational
carcinogen, with no further categorization. EPA – U.S.
Environmental Protection Agency; A = Human carcinogen, B =
Probable human carcinogen, C = Possible human carcinogen, D =
Not classifiable as to human carcinogenicity, E = Evidence of Noncarcinogenicity
for humans, K = Known human carcinogen, L =
Likely to produce cancer in humans, CBD = Cannot be determined,
NL = Not likely to be carcinogenic in humans, and I = Data are
inadequate for an assessment of human carcinogenic potential.
REGULATORY INFORMATION:
This section explains the impact of various laws and regulations on
the material. EPA is the U.S. Environmental Protection Agency.
WHMIS is the Canadian Workplace Hazardous Materials Information
System. DOT and TC are the U.S. Department of Transportation
and the Transport Canada, respectively.
Superfund Amendments and Reauthorization Act (SARA); the
Canadian Domestic/Non-Domestic Substances List (DSL/NDSL);
the U.S. Toxic Substance Control Act (TSCA); Marine Pollutant
status according to the DOT; the Comprehensive Environmental
Response, Compensation, and Liability Act (CERCLA or
Superfund); and various state regulations. This section also
includes information on the precautionary warnings that appear on a
material’s industrial package label.
0135RA0706D-1 (09/06)