510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QMAClass II

Blood Collection Device For Cell-Free Nucleic Acid

21 CFR 862.1676 / Clinical Chemistry
FDA source (opens on fda.gov)

QMA is the FDA product code for Blood Collection Device For Cell-Free Nucleic Acid, a class II device type, regulated under 21 CFR 862.1676. FDA's definition for this code reads: "A blood collection device for cell-free nucleic acids is a device intended for medical purposes to collect, store, transport, and handle blood specimens and to stabilize and isolate cell-free nucleic acid components prior to further testing". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QMA
Device name
Blood Collection Device For Cell-Free Nucleic Acid
FDA definition
A blood collection device for cell-free nucleic acids is a device intended for medical purposes to collect, store, transport, and handle blood specimens and to stabilize and isolate cell-free nucleic acid components prior to further testing.
Regulation
21 CFR 862.1676
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QMA

By decision year
2 clearances under product code QMA with a decision year between 2020 and 2024, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QMA by decision year
YearClearances
20201
20241

Applicants with the most clearances

Product code QMA
Applicants holding the most 510(k) clearances under product code QMA
ApplicantClearances
Streck LLC2

Companies listing this code with FDA

Companies whose registered establishments list this code