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

Blood Grouping Reagent

21 CFR 660.20 / Hematology
FDA source (opens on fda.gov)

QHR is the FDA product code for Blood Grouping Reagent, regulated under 21 CFR 660.20. FDA's definition for this code reads: "For red blood cell antigen typing". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
QHR
Device name
Blood Grouping Reagent
FDA definition
For red blood cell antigen typing
Regulation
21 CFR 660.20
Device class
Unclassified
Review panel
Hematology
Submission type
Contact ODE
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code QHR.