← FDA Medical Device Classifications

Reagents And Transportation Supplies, Sodium Citrate Blood Specimen Collection Tube

QPW · Not classified · Unknown

Classification

FDA Product Code
QPW
Device class
Not classified
Regulation
Review panel
HE
Medical specialty
Unknown
Submission type
8
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Definition

A blood collection tube intended for emergency use in healthcare settings to collect, transport, and store blood specimens for coagulation testing to aid in the identification and treatment of coagulopathy in patients with known or suspected COVID-19.

Market data

Cleared 510(k) submissions
0
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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