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Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
FDA product code KQP · Class 2 · Clinical Chemistry
14
Registered devices
0
Adverse events
1
Recalls
7
510(k) clearances
Devices with this code
SPOTCHECK — ASTORIA-PACIFIC, INC.SPOTCHECK — ASTORIA-PACIFIC, INC.SPOTCHECK — ASTORIA-PACIFIC, INC.SPOTCHECK — ASTORIA-PACIFIC, INC.Neonatal GALT kit — Wallac OySPOTCHECK — ASTORIA-PACIFIC, INC.SPOTCHECK — ASTORIA-PACIFIC, INC.SPOTCHECK — ASTORIA-PACIFIC, INC.SPOTCHECK — ASTORIA-PACIFIC, INC.GSP Neonatal GALT kit — Wallac OySPOTCHECK — ASTORIA-PACIFIC, INC.TiLock — Genesys Orthopedics Systems LLCNeonatal GALT kit — Wallac OySPOTCHECK — ASTORIA-PACIFIC, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-18 | WALLAC OY | Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient r |
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