General Information
Revision date
2024-05-13
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
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
Danger
Hazard Codes
Hazard statements (CLP)
H301, H311, H314, H317, H318, H331, H341, H350, H370
Hazard statements
Code
Statements
H301
Toxic if swallowed
Section 2
2.1 Classification of the substance or mixture
Regulation (EC) No Cat. H code Symbol Signal Classification
Hazard pictograms
Corrosion (GHS05), Exclamation Mark (GHS07), Health Hazard (GHS08), Skull & Crossbones (GHS06)
Signal word
Danger
2.2 Label elements
Container labeling is not required on medical devices per 29CFR1910.1200(b)(5)(iii) & Directive 98/79/EC Title I, Article 1,5(d).
Hazard statements
H370 Causes damage to organs via dermal, oral, and respiratory routes. H350 May cause cancer H341 Suspected of causing genetic defects H317 May cause an allergic skin reaction H314 Causes severe skin burns and eye damage H318 Causes serious eye irritation H311 Toxic in contact with skin H331 Toxic if inhaled H301 Toxic if swallowed
Precautionary statements
P201 + P202 + Do not handle until all safety precautions have been read and understood. Use P281 personal protective equipment as required. P260 + P270 + Do not breathe dust/fume/gas/mist/vapors/spray. Use only outdoors or in a well- P271 ventilated area. Do not eat, drink or smoke when using this product. P233 + P403 + P405 + P501 Keep container tightly closed. Store in a well-ventilated place. Store locked up. Dispose of contents/container of unused BCTs as non-hazardous waste. Dispose of used BCTs in the same manner as patient samples. P264 Wash skin thoroughly after handling. P303 + P361 + P352 + P353 + IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Wash contaminated clothing before reuse. Rinse skin with water/shower. Wash with plenty of P363 + P313 + soap and water. If skin irritation or rash occurs: Get medical advice/attention. Call a P333 + P312 POISON CENTER or doctor/physician if you feel unwell. P305 + P310 + IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if P351 + P338 present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor/physician. P304 + P340 + IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for P307 + P311 breathing. If exposed: Call a POISON CENTER or doctor/physician P301 + P310 + IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician. Rinse P330 + P331 + mouth. Do NOT induce vomiting. If exposed: Call a POISON CENTER or P307 + P311 doctor/physician P308 + P313 If exposed or concerned: Get medical advice/ attention.
2.3 Other hazards
N/A
