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Safety Data Sheet EN

Determine™ HIV-1/2 Ag/Ab Combo, Test Device

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01

Identification

Product identifiers, regulatory numbers, and supplier information

Product Information

Product Name
Determine™ HIV-1/2 Ag/Ab Combo, Test Device
Product Code
7D2648, 7D2649

Regulatory Identifiers

CAS Number
N/A

Identified Uses

In vitro diagnostic reagent. For professional use only.

Manufacturers & Suppliers

A

Abbott Diagnostics Scarborough, Inc.

manufacturer

10 Southgate Road, Scarborough, ME 04074 - United States

+1 (207) 730-5750

Emergency Contacts

Emergency Contact

+1 (800) 424-9300

02

Hazard Identification

GHS classification, signal word, pictograms, and hazard statements

Classified no signal word

GHS Pictograms

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03

Composition / Information on Ingredients

Chemical components, concentration ranges, and hazardous substance identification

Type mixture

The product does not contain reportable quantities of dangerous components.

04

First Aid Measures

Emergency procedures for chemical exposure incidents

Inhalation

Supply fresh air; consult doctor in case of complaint.

Skin contact

Wash skin with soap and water.

Eye contact

Rinse cautiously with water for several minutes. Consult doctor in case of complaint.

Ingestion

Wash out mouth with water. Consult a doctor.

05

Firefighting Measures

Extinguishing media, specific hazards, and firefighter protection

Suitable media

CO2, powder or water spray. Fight larger fires with water spray or alcohol resistant foam.

Specific hazards

In case of fire, the following can be released: Hazardous fumes, Carbon oxides (COx). nitrogen oxides (NOx)

Firefighter Protection

Wear full protective suit and self-contained breathing apparatus (SCBA) when extinguishing fires.

06

Accidental Release Measures

Spill cleanup procedures, containment, and environmental protection

Emergency procedures

Refer to Section 8 for protective measures when handling the spillage.

Environmental

Avoid release to the environment.

Cleanup methods

Collect material

—

Related Products

Similar products with comparable safety profiles

07

Handling and Storage

Safe handling precautions, storage conditions, and workplace requirements

Handling

This product should be handled as a potentially infectious material, as no known test method can offer complete assurance that materials of human origin will not transmit infectious agents. Specimens should be handled as potentially infectious materials. Refer to OSHA Regulation 29 CFR 1910.1030 for handling biohazardous materials. Avoid contact with the eyes, skin and mucous membranes. Keep out of reach of children.

Storage

Store in original container at 2 to 30°C.

Hygiene

Wash hands before breaks and after work. Clean work areas with hypochlorite or other disinfecting agent.

08

Exposure Controls / PPE

Occupational exposure limits, engineering controls, and protective equipment

Engineering

Not relevant for this material.

Hands

Disposable gloves. Material of gloves: Latex / natural rubber, Nitrile rubber. Penetration time of glove material: Gloves resistance is not critical when the product is handled according to the instructions for use.

Eyes

Safety glasses recommended.

Respiratory

Not normally required.

Skin/Body

Laboratory coat.

Environmental

No special measures are required.

09

Physical and Chemical Properties

Appearance, physical state, melting point, boiling point, and material characteristics

Language Code
---
Physical State
solid
Physical State Data
solid
State Under Standard Conditions
---
Appearance
Laminated test strip consisting of solid support materials impregnated with dried chemical / biochemical reagents.
Colour
White.
Colour Intensity
---
Form
---
Odor
No odour.
Odor Threshold
Not applicable
Ph
Not determined
Melting Point
Not determined
Boiling Point
Not determined
Flash Point
Not applicable
Freezing Point
---
Softening Point
---
Solidification Point
---
Cloud Point
---
Crystallisation Point
---
Relative Evaporation Rate
---
Evaporation Rate
Not applicable
Vapor Pressure
Not applicable
Vapor Density
Not applicable
Relative Density
---
Bulk Density
---
Density
Not determined
Flammability
Not determined
Upper Explosive Limit
Not applicable
Lower Explosive Limit
Not applicable
Explosive Limits
---
Auto Ignition Temperature
Not determined
Decomposition Temperature
Not determined
Solubility
Not determined
Partition Coefficient
Not determined
Solubility In Water
Not determined
Solubility In Fat
---
Molecular Weight
---
Voc Content
---
Metal Corrosion
---
Dynamic Viscosity
Not determined
Kinematic Viscosity
---
Properties Status
---
10

Stability and Reactivity

Chemical stability, hazardous reactions, and incompatible materials

Stability

The product is stable in accordance with the recommended storage conditions.

Reactivity

None known.

Hazardous reactions

Contact with acids may liberate trace amounts of toxic gas (hydrazoic acid). Hazardous polymerisation will not occur.

Incompatible

Strong Acids, Strong Alkalis, Strong oxidising agents.

Decomposition

None known.

12

Ecological Information

Environmental toxicity, biodegradation, and bioaccumulation data

12.1 Toxicity

The product does not contain significant quantities of ingredients that are environmentally toxic.

The product does not contain significant quantities of ingredients that are environmentally toxic.

12.2 Persistence and degradability

The product is likely to persist in the environment.

The product is likely to persist in the environment.

12.3 Bioaccumulative potential

None anticipated.

None anticipated.

12.4 Mobility in soil

The product is predicted to have low mobility in soil.

The product is predicted to have low mobility in soil.

12.5 Results of PBT and vPvB assessment

Not applicable

Not applicable

12.6 Other adverse effects

Not applicable

Not applicable

13

Disposal Considerations

Waste treatment methods, disposal recommendations, and waste codes

Treatment

Used devices should be disposed of as potentially biohazardous material in compliance with anti-pollution and other laws of the country concerned.

Disposal

We recommend that you contact the relevant (local) authorities and/or an approved waste-disposal company for information.

14

Transport Information

UN numbers, shipping names, transport classes, and regulatory requirements

15

Regulatory Information

Chemical regulations, safety assessments, and compliance status

?

Frequently Asked Questions

Common questions about safety, handling, and properties

What is the hazard signal word for Determine™ HIV-1/2 Ag/Ab Combo, Test Device?

The signal word is no signal word.

What is the physical form of Determine™ HIV-1/2 Ag/Ab Combo, Test Device?

Determine™ HIV-1/2 Ag/Ab Combo, Test Device is a solid appearing as laminated test strip consisting of solid support materials impregnated with dried chemical / biochemical reagents. with white. color. It has no odour. odor.

What is the solubility of Determine™ HIV-1/2 Ag/Ab Combo, Test Device?

Not determined

What is Determine™ HIV-1/2 Ag/Ab Combo, Test Device used for?

In vitro diagnostic reagent. For professional use only.

What is the melting point of Determine™ HIV-1/2 Ag/Ab Combo, Test Device?

The melting point is Not determined and the boiling point is Not determined.