Cell-Free DNA BCT CE

Streck

Revision date : 2025-09-10

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GHS07 GHS08
Health risk rating 4
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

254-372-6/39236-46-9

Name of the chemical

N,N″-methylenebis[N′-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]

Concentration

≤50%

General Information

Revision date

2025-09-10

Product name

Cell-Free DNA BCT CE

1.2.1 Relevant identified uses

Stabilization of cell-free plasma DNA

1.2.2. Uses advised against

Refer to Instructions for Use (IFU) for additional precautions and limitations Reasons Product is classified as an In Vitro Diagnostic device

Manufacturer Name

Streck

Emergency telephone

1-402-333-1982, 1-800-255-3924

Icons in SDS

GHS07 GHS08 M004 M009 M010 M011 M013

Company Information

company name

Streck

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

jhopkins@streck.com

GHS Information

Signal word

Warning

Hazard Codes

Hazard statements (CLP)

H317, H373

Hazard statements

Code

Statements

H317

May cause an allergic skin reaction

Section 2

SECTION 2: Hazards identification

1272/2008 Product is < 0.22ml of self-contained solution and hazards are neutralized upon sample collection. Refer to IFU for proper handling. Classification Regulation (EC) No Cat H code Symbol Signal Classification

2.2 Label elements

Container labeling is not required on medical devices per 29CFR1910.1200(b)(5)(iii) & Regulation (EU) 2017/746.

Hazard statements

H317 May cause an allergic skin reaction H332 Harmful if inhaled H373 May cause damage to organs through prolonged or repeated exposure

Precautionary statements

P260 Do not breathe dust/fume/gas/mist/vapors/spray P302 + P352 + IF ON SKIN: Wash with plenty of soap and water. P304 + P340 + IF INHALED: Remove person to fresh air and keep comfortable for breathing.

2.1 Classification of the substance or mixture

Regulation (EC) No Cat. H code Symbol Signal Classification 1272/2008 [CLP] Word Procedures Acute Toxicity Inhalation: 4 H332 Exclamation Warning Bridging principles: Dilution Skin Sensitization: 1B H317 Exclamation Warning Specific target organ toxicity: 2 H373 Health Warning Repeated Exposure Hazard Respiratory Hazard pictograms: Exclamation Mark (GHS07), Health Hazard (GHS08) Signal Word: Warning

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