Valid 08/2002 - 10/2002

M A T E R I A L S A F E T Y D A T A S H E E T
INOVA Diagnostics, Inc. Revision Date: 03/04/10 9900 Old Grove Road San Diego, CA 92131 U.S.A.
General information telephone number: 858/586-9900
Emergency telephone number: 858/586-9900
SECTION 1. - - - - - - - - - - - - - - - - - PRODUCT IDENTIFICATION - - - - - - - - - - - - - - - - - - - - - - - - - - - -
CATALOG #: 704615
NAME: QUANTA LiteTM HA dsDNA ELISA
USE: For In Vitro Diagnostic Use, CLIA Complexity: High
SECTION 2. - - - - - - - - - - COMPOSITION/INFORMATION ON INGREDIENTS - - - - - - - - - - - - - - - - - -
Kit components
NOTE: P/N = Product Number
P/N 504615, Polystyrene microwell ELISA plate coated with calf thymus dsDNA antigen
P/N 508556, ELISA Negative Control, 1 vial containing <0.1% Sodium Azide, ≤0.02% Chloramphenicol and human serum
with no known human antibodies to dsDNA
P/N 504617, HA dsDNA Positive Control, 1 vial containing <0.1% Sodium Azide, ≤0.02% Chloramphenicol and human serum
antibodies to dsDNA
P/N 504618, HA dsDNA Single Stranded Control, 1 vial containing <0.1% Sodium Azide, ≤0.02% Chloramphenicol and human
serum antibodies to ssDNA
P/N 504616A, HA dsDNA ELISA Calibrator A, 1 vial containing <0.1% Sodium Azide, ≤0.02% Chloramphenicol and human
serum antibodies to dsDNA
P/N 504616B, HA dsDNA ELISA Calibrator B, 1 vial containing <0.1% Sodium Azide, ≤0.02% Chloramphenicol and human
serum antibodies to dsDNA
P/N 504616C, HA dsDNA ELISA Calibrator C, 1 vial containing <0.1% Sodium Azide, ≤0.02% Chloramphenicol and human
serum antibodies to dsDNA
P/N 504616D, HA dsDNA ELISA Calibrator D, 1 vial containing <0.1% Sodium Azide, ≤0.02% Chloramphenicol and human
serum antibodies to dsDNA
P/N 504616E, HA dsDNA ELISA Calibrator E, 1 vial containing <0.1% Sodium Azide, ≤0.02% Chloramphenicol and human
serum antibodies to dsDNA
P/N 504002, Type III Sample Diluent, 2 vials containing Tris-buffered saline, <0.2% Tween 20, ≤0.02% Chloramphenicol and
<0.1% Sodium Azide
P/N 504001, HA dsDNA Wash Concentrate (10x), 2 vials of concentrate containing Tris-buffered saline and >1% Tween 20
P/N 504619, HRP HA dsDNA IgG Conjugate (goat), anti-human IgG, 1 vial containing buffer, protein ≤0.02%
Chloramphenicol and <0.1% Sodium Azide
P/N 508504, TMB (3,3’,5,5’-tetramethylbenzidine) <0.02%, 1 vial
P/N 508509, HRP Stop Solution, 1 vial containing <2% Sulfuric Acid
SECTION 3. - - - - - - - - - - - - - - - - - HAZARDS IDENTIFICATION - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Primary Health Hazards:
Some reagents contain less than (<) 0.1% total weight of Sodium Azide (NaN3) as a preservative, CAS # 26628-22-8, EINECS #
247-852-1 Some reagents contain less than or equal to (≤) 0.02% total weight Chloramphenicol as a preservative, CAS # 56-75-7, EINECS # 200-287-4 Some reagents contain less than or equal to (<) 0.2% Tween 20 as a stabilizer, CAS# 9005-64-5, EINECS# None TMB (3,3’,5,5’-tetramethylbenzidine) is less than or equal to (<) 0.02%, CAS # 54827-17-7, EINECS # 259-364-6 Sulfuric Acid is less than (<) 2%, CAS # 7664-93-9, EINECS # 231-639-5 Human Source Material: Treat as potentially infectious. Serum used in the preparation of this product has been tested by FDA approved methods and found non-reactive for the presence of Hepatitis B surface antigen (HBsAg), antibody to human immunodeficiency virus (HIV) and Hepatitis C virus (HCV). No known test method can offer complete assurance that Hepatitis B virus, HIV, HCV, or other infectious agents are absent. Handle these controls and all patient samples at Biosafety Level 2 as recommended in the Biosafety in Microbiological and Biomedical Laboratories, Centers for Disease Control and Prevention/National Institutes of Health, Fifth Edition, 2007. INOVA Diagnostics, Inc. 9900 Old Grove Road San Diego, CA 92131-1638, USA Tel. +1 858 586 9900 – Fax: +1 858 586 9911 NOTE: Physical and health hazard information for the kit has not been determined. Any physical and health information noted is based on evaluation of data for pure ingredients and concentration of ingredients as packaged. Target Organs: None identified.
SECTION 4. - - - - - - - - - - - - - - - - - - - - FIRST-AID MEASURES - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Eye: Rinse immediately with plenty of clean running water for at least 20 minutes, separating the eyelid.
Skin Contact: Wash off thoroughly with plenty of clean running water. Remove and wash contaminated clothing.
Ingestion: Obtain medical attention.
Inhalation: Remove from exposure. If breathing is difficult, obtain medical attention if necessary.
IN CASE OF ACCIDENT OR IF YOU DO NOT FEEL WELL, IMMEDIATELY SEEK MEDICAL ADVICE.

SECTION 5. - - - - - - - - - - - - - - - - - - - - FIRE FIGHTING MEASURES - - - - - - - - - - - - - - - - - - - - - - - - -
Non-flammable preparation.
Extinguishing media: Use media in adaption to materials stored in the immediate neighborhood, such as dry chemical.
Special firefighting procedures: Wear self-contained breathing apparatus and protective clothing to prevent contact with skin and
eyes.
NFPA: HEALTH = 0, FLAMMABILITY = 0, REACTIVITY = 0
SECTION 6. - - - - - - - - - - - - - - - - ACCIDENTAL RELEASE MEASURES - - - - - - - - -- - - - - - - - - - - - - -
After spillage: Wipe up spills with inert absorbent materials and place in a suitable container. Use personal protective
equipment (PPE), such as gloves, safety glasses/goggles to prevent exposure.
SECTION 7. - - - - - - - - - - - - - - - - - - - HANDLING AND STORAGE - - - - - - - - - - - - - - - - - - - - - - - - - - -
Handling: Normal precautions for handling chemicals must be observed. Wash affected area after handling.
Storage: Keep containers tightly closed when not in use. Store in a dry, well ventilated storage area (2-8°C). Protect from
physical damage.
SECTION 8. - - - - - - - - - - - EXPOSURE CONTROLS/PERSONAL PROTECTION - - - - - - - - - - - - - - - -
Respiratory protection: Good local ventilation.
Eye protection: Protective glasses.
Hand protection: One-way gloves (latex or nitrile).
Use protective lab coat.
Recommend the use of safety pipette device.
SECTION 9. - - - - - - - - - - - - - PHYSICAL AND CHEMICAL PROPERTIES - - - - - - - - - - - - - - - - - - - - -
Appearance:
Microtiter plate: solid polystyrene plastic
Conjugate: blue liquid
Type III Sample Diluent: yellow liquid
HA dsDNA Positive Control: pink liquid
HA dsDNA Single Stranded Control: pink liquid
Calibrator A: pink liquid
Calibrator B: pink liquid
Calibrator C: pink liquid
Calibrator D: pink liquid
Calibrator E: pink liquid
Negative Control: pink liquid
HA dsDNA Wash Concentrate: colorless liquid
TMB: pale yellow liquid (possibly exhibiting a slight blue tinge)
Stop Solution: colorless liquid
Odor: Solutions are odorless
Boiling point: N/A
Melting point: N/A
Flash point: N/A
Ignition temperature: N/A
Explosion limits: N/A
Vapor pressure: N/A
Density: N/A
Viscosity: N/A
Solubility in water: Solutions are soluble
SECTION 10. - - - - - - - - - - - - - - - - - - STABILITY AND REACTIVITY - - - - - - - - - - - - - - - - - - - - - - - - -
Stability: Stable under ordinary conditions of use and storage.
Hazardous Polymerization: Will not occur.
Conditions and materials to avoid: N/A
Hazardous reactions: N/A
Hazardous decomposition products: N/A
SECTION 11. - - - - - - - - - - - - - - - - - TOXICOLOGICAL INFORMATION - - - - - - - - - - - - - - - - - - - - - - -
The toxicological properties of this kit and/or its components have not been fully investigated, data not available.
Teratogenicity: Data not available.
Reproductive effects: Data not available.
Neurotoxicity: Data not available.
Mutagenicity: Data not available.
SECTION 12. - - - - - - - - - - - - - - - - - - ECOLOGICAL INFORMATION - - - - - - - - - - - - - - - - - - - - - - - - -
Data not available.

SECTION 13. - - - - - - - - - - - - - - - - DISPOSAL CONSIDERATIONS - - - - - - - - - - - - - - - - - - - - - - - - - -
Observe all Governmental environmental regulations for waste disposal. Chemical waste generators must determine if a
discarded chemical is classified as a hazardous waste. Contact a licensed professional waste disposal service for disposal of
unused product.
Remains of biological samples, reagents and controls should be collected in a suitable container for this purpose and autoclaved 1
hour at 121ºC.
RCRA P-Series: None listed.
RCRA U-Series: None listed.
SECTION 14. - - - - - - - - - - - - - - - - - TRANSPORT INFORMATION - - - - - - - - - - - - - - - - - - - - - - - - - - -
Special requirements: None.
.
SECTION 15. - - - - - - - - - - - - - - - - REGULATORY INFORMATION - - - - - - - - - - - - - - - - - - - - - - - - - -
According to 1999/45/EC Directive and 91/155/EEC Directive and following modifications.
OSHA Hazards:
No known OSHA hazards.
TSCA Status:
Not on TSCA Inventory.
Antibody, solid.
CAS-No. = None
DSL Status
This product contains the following components that are not on the Canadian DSL nor NDSL lists.
Antibody, solid
CAS-No. = None
SARA 302 Components:
SARA 302: No chemicals in this material are subject to the reporting requirements of SARA Title III, Section 302.
SARA 313 Components:
SARA 313: This material does not contain any chemical components with known CAS numbers that exceed the threshold (De
Minimis) reporting levels established by SARA Title III, Section 313.
SARA 311/312 Hazards:
No SARA Hazards
Massachusetts Right To Know Components:
No Components Listed
Pennsylvania Right To Know Components:
No Components Listed
New Jersey Right To Know Components:
No Components Listed
California Prop. 65 Components:
This product does not contain any chemicals known to State of California to cause cancer, birth, or any other reproductive
defects.
SECTION 16. - - - - - - - - - - - - - - - - - - - OTHER INFORMATION - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Some reagents in this kit contain Sodium Azide as a preservative. Sodium Azide has been reported to form lead or Copper Azide
in laboratory plumbing which may explode on percussion. Use proper disposal procedures.
Each donor unit used in the preparation of the controls of this kit was tested by an approved method for the presence of the
antibodies to HIV and HCV as well as for HBsAg and found to be negative. WARNING: Because no test method can offer
complete assurance that HIV, HCV, HBsAg or other infectious agents are absent, the controls of this kit should be handled
carefully using Universal Precautions.
INOVA Diagnostics, Inc. 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
material by properly trained personnel using this product. Individuals receiving the information must exercise their independent
judgment in determining its appropriateness for a particular purpose. INOVA Diagnostics, Inc. makes no representations or
warranties, either express or implied, including without limitation any warranties of merchantability, fitness for a particular
purpose with the respect to the information set forth herein or the product to which the information refers. Accordingly, INOVA
Diagnostics, Inc. will not be liable for any claims, losses or damages resulting from use of or reliance upon this information.
Copyright 2010 INOVA Diagnostics, Inc.

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