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Reagent - Biokit

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BIOKIT S.A.<br />

08186 Llissà d'Amunt<br />

(Barcelona) Spain<br />

Phone: (34) 93 860 9000<br />

Fax: (34) 93 860 9029<br />

e-mail: biokit@biokit.com<br />

SAFETY DATA SHEET<br />

Code: 3000-8010<br />

Date: 14-06-05 Rev.: 02<br />

Pag.: 1 of 3<br />

1. Identification of preparation<br />

Product name: rotagen<br />

2. Composition/information on ingredients<br />

Kit components:<br />

Antigen <strong>Reagent</strong>: Suspension of polystyrene latex particles coated with rabbit anti-rotavirus immunoglobulins in a buffer.<br />

Contains


BIOKIT S.A.<br />

08186 Llissà d'Amunt<br />

(Barcelona) Spain<br />

Phone: (34) 93 860 9000<br />

Fax: (34) 93 860 9029<br />

e-mail: biokit@biokit.com<br />

SAFETY DATA SHEET<br />

Code: 3000-8010<br />

Date: 14-06-05 Rev.: 02<br />

Pag.: 2 of 3<br />

9. Physical and chemical properties<br />

Appearance:<br />

Antigen <strong>Reagent</strong>: white suspension<br />

Control <strong>Reagent</strong>: white suspension<br />

Positive Control: colourless suspension<br />

Diluent: colourless liquid<br />

Odour: Odourless<br />

Boiling point: N/A<br />

Melting point: N/A<br />

Flash point: N/A<br />

Ignition temperature: N/A<br />

Explosion limits: N/A<br />

Vapour pressure: N/A<br />

Density: N/A<br />

Viscosity: N/A<br />

Solubility in water: soluble<br />

10. Stability and reactivity<br />

Conditions and materials to avoid: N/A<br />

Hazardous reactions: N/A<br />

Hazardous descomposition products: N/A<br />

11. Toxicological information<br />

Data not available.<br />

12. Ecological information<br />

Data not available.<br />

13. Disposal considerations<br />

Remains of samples, reagents and controls should be collected in a recipient for this purpose and autoclaved 1 hour at 121ºC.<br />

Observe all Federal, State and local laws.<br />

14. Transport information<br />

Special requirements: None<br />

15. Regulatory information<br />

According to 1999/45/EC Directive and 91/155/EEC Directive and following modifications.


BIOKIT S.A.<br />

08186 Llissà d'Amunt<br />

(Barcelona) Spain<br />

Phone: (34) 93 860 9000<br />

Fax: (34) 93 860 9029<br />

e-mail: biokit@biokit.com<br />

SAFETY DATA SHEET<br />

Code: 3000-8010<br />

Date: 14-06-05 Rev.: 02<br />

Pag.: 3 of 3<br />

16. Other information<br />

Intended use: Rapid qualitative test for the direct detection of rotavirus group antigen in feces by agglutination of latex particles on<br />

slide.<br />

For IN VITRO diagnostic use.<br />

All reagents in this kit contain sodium azide as a preservative. Sodium azide has been reported to form lead or copper azide in<br />

laboratory plumbing which may explode on percusion. Use proper disposal procedures.<br />

WARNING: POTENTIALLY BIOHAZARDOUS MATERIAL<br />

While the rotavirus antigen in the preparation of this kit has been inactivated, no method of inactivation can offer complete<br />

assurance of non-infectivity. Therefore, the positive control contained in this kit should be handled using appropriate precautions.<br />

The above information is believed to be correct, but does not purpose to be all inclusive and should be used only as a guide.<br />

BIOKIT S.A. shall not be held for any damage resulting from handling or use of the product.

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