KQP · Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
Clinical Chemistry · 21 CFR 862.1315 · Class 2
Overview
| Product Code | KQP |
|---|---|
| Device Name | Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase |
| Regulation | 21 CFR 862.1315 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A galactose-1-phosphate uridyl transferase test system is a device intended to measure the activity of the enzyme galactose-1-phosphate uridyl transferase in erythrocytes (red blood cells). Measurements of galactose-1-phosphate uridyl transferase are used in the diagnosis and treatment of the hereditary disease galactosemia (disorder of galactose metabolism) in infants.
Classification Rationale
Class II.
Cleared Devices (7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K102643 | SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT | Astoria-Pacific, Inc. | Jul 15, 2011 | SESE |
| K101392 | NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D | Astoria-Pacific, Inc. | Feb 4, 2011 | SESE |
| K100101 | GSP NEONATALGALT KIT, MODEL 3303-001U | Perkinelmer, Inc. | Jun 11, 2010 | SESE |
| K993536 | BIO-RAD CODA NEONATAL GALT ASSAY | Bio-Rad | Nov 4, 1999 | SESE |
| K990827 | MICROPLATE NEONATAL GALT ASSAY | Bio-Rad | Apr 9, 1999 | SESE |
| K970277 | URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) | Astoria-Pacific, Inc. | Dec 11, 1997 | SESE |
| K894011 | TOTAL GALACTOSE | Alpkem Corp. | Jan 11, 1990 | SESE |
Top Applicants
- Astoria-Pacific, Inc. — 3 clearances
- Bio-Rad — 2 clearances
- Perkinelmer, Inc. — 1 clearance
- Alpkem Corp. — 1 clearance
