NeuMoDx EBV External Controls

QIAGEN GmbH

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Health risk rating
Safety risk rating
Environmental risk rating

Note: Ingredients listed on restricted chemical lists

EC/CAS

247-852-1/26628-22-8

Name of the chemical

Sodium Azide

Concentration

0.02%

General Information

Product name

NeuMoDx EBV External Controls

1.2.1 Relevant identified uses

For in vitro diagnostic use

Manufacturer Name

NeuMoDx Molecular, Inc

Emergency telephone

1-800-222-1222

Icons in SDS

Company Information

company name

QIAGEN GmbH

e-mail address of the competent person responsible for the Safety Data Sheet

info@neumodx.com

GHS Information

Signal word

Not required

Section 2

SECTION 2: Hazards identification

Regulation (EC) No. 1272/2008 [CLP]] OSHA Hazards EU/EEC

2.2 Label elements

Not required.

Signal word

Not required. Hazard Pictograms/statements: Not required.

Precautionary statements

Not required.

2.3 Other hazards

None.

2.1 Classification of the substance or mixture

The product has not been fully tested as hazardous according to the Globally Harmonized System (GHS). CLP The NeuMoDx EBV External Controls are the final finished products for use on the NeuMoDx Molecular System. The NeuMoDx EBV External Controls are provided in a kit comprised of 30 tubes of Basematrix - 15 tubes with non-hazardous EBV target added (positive control) and 15 tubes without (negative control). The final solution is yellow-tan liquid. This product contains material derived from human plasma. Vendors responsible for the materials going into the NeuMoDx EBV External Control Kit have stated that the human source material has been tested and shown by FDA approved methods to be free from antibodies to Human Immune Deficiency Virus and Hepatitis C and is non-reactive for HBsAg and anti- HIV-1/2, anti-EBV, anti-HTLV I/II, anti-HBs, and anti-HBc. Exemptions for disclosing some component information are pursuant to CLP Article 1(5)(d) and 29 CFR 1910. 1200(g)(2)(i)(C)(1)&(2). Product contains sodium azide as a preservation at a concentration below threshold amount for reporting according to OSHA hazard communication regulations (1%) but at a concentration that should be considered for disposal and other environmental considerations.

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