510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
QHSUnclassified

Anti-Human Globulin

21 CFR 660.50 / Hematology
FDA source (opens on fda.gov)

QHS is the FDA product code for Anti-Human Globulin, regulated under 21 CFR 660.50. FDA's definition for this code reads: "For the performance of direct and indirect antiglobulin tests in blood banking/ immunohematology". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QHS
Device name
Anti-Human Globulin
FDA definition
For the performance of direct and indirect antiglobulin tests in blood banking/ immunohematology
Regulation
21 CFR 660.50
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
0

Companies listing this code with FDA

Companies whose registered establishments list this code