General Information
Revision date
2021-04-16
Product name
INSTI HIV-1 / HIV-2 Antibody Test Kit
1.2.1 Relevant identified uses
human venipuncture whole blood, fingerstick blood, serum, or plasma specimens. The test is intended
Manufacturer Name
Toll Free: 1-866-674-6784
Icons in SDS
Company Information
company name
bioLytical Laboratories Inc
e-mail address of the competent person responsible for the Safety Data Sheet
info@bioLytical.com
GHS Information
Signal word
Warning
Hazard Codes
Hazard statements (CLP)
H302, H413
Hazard statements
Code
Statements
H302
Harmful if swallowed
Section 2
2.1 Classification of the substance or mixture
Hazardous Components of Mixture Present Kit Component1 Description Above Threshold Levels2 Foil sealed membrane unit containing Membrane Unit nitrocellulose membrane and nylon fibre None absorbent pad. Sample Diluent Solution 1, containing 1.5 mL of Tris-glycine None3 buffered solution containing cell lysis reagents. Solution 2, containing 1.5 mL or 85 mL (48 Tests Colour Developer Kit) of a blue-coloured Borate buffered None3 proprietary indicator solution. Solution 3, containing 1.5 ml or 85 mL (48 Tests Clarifying Solution Kit) of a proprietary Tris-glycine buffered None3 clarifying solution. White and blue droppers with closure. Bulb: Droppers (48 test kits Monprene; Pipette: Low-density polyethylene None only) (LDPE); Closure: Polypropylene; Bag: Polyethylene Disposable Transfer Low-density polyethylene (LDPE) None Pipette Alcohol Swab
Contains
70% IPA None Lancet Sterile single-use safety lancets None 1Components of the package may vary based on the configuration 2According to the OSHA Hazard Communication Standard (29 CFR 1910.1200), if a mixture contains less than 1% of a hazardous chemical or 0.1% of a carcinogen, the mixture shall not be considered hazardous. Under GHS, the cut-off level for reproductive toxicity, carcinogenicity and category 1 mutagenicity is ≥ 0.1%. The cut-off level for all other hazard class is ≥1%. 3Sample Diluent, Colour Developer and Clarifying Solution contains 0.1% Sodium Azide (NaN3, EC No 247-852-1 and CAS# 26628- 22-8) as a preservative. GHS label elements, precautionary statements: Kit Component GHS label elements, precautionary statements: Component of Sodium Azide 0.1% Sodium azide [NaN3], CAS# 26628-22-8 and EC No 247-852-1 (≥ 0.1% dilution < 1%) GHS \ 2008/1272/EC Classification: Label(s): GHS07 Sample Diluent, Colour
Signal word
WARNING Developer, Clarifying Label Hazard Statement: H302: Harmful if swallowed Solution H413: May cause long lasting harmful effects to aquatic life.
Supplemental label elements
None Specified. 0.1% sodium azide as
Prevention
P264: Wash thoroughly after handling. preservative P270: Do not eat, drink or smoke when using this product. P273: Avoid release to the environment.
Response
P330: Rinse mouth. P301 + P312 IF SWALLOWED Call a POISON CENTER or doctor/physician if you feel unwell.
Storage
None Specified
Precautionary statements
Disposal P501: Dispose of contents and container in accordance to local, regional, national and/or international regulations. This material and its container must be disposed of in a safe way. Hazards not otherwise 2.3 covered None