Panels › Hematology › Product code NPR · Class 2
Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
Regulation 864.7280
0510(k)s in 12 months (5 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in NPR
| Company | 510(k)s | Recalls |
|---|---|---|
| Cepheid | 2 | 0 |
| Roche Molecular Systems, Inc. | 1 | 1 |
| Hologic, Inc. | 1 | 0 |
| Roche Diagnostics Corp. | 1 | 0 |
| Roche Diagnostics Operations, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 14, 2011 | Roche Diagnostics Operations, Inc. Factor II (prothrombin) G20210A kit, catalog number 03610195001, Roche Diagnostics, Indianapolis, IN
The Factor II (prothrombin) G20210A kit allows the detection and genotyping of a single point Terminated |
NPR | K033612 |
| Mar 5, 2010 | Roche Molecular Systems, Inc. FACTOR II (PROTHROMBIN) G20210A Kit, LightCycler 2.0 Instrument. Material Number 03610195 001
Cont.
1 FIIG20210A MD Mix, 1 x 78 uL
2. FIIG20210A R mix, 1 x 78 uL
3. FIIG20210A CT, 1 x 50 uL
5, FIIG20 Terminated |
NPR | K033612 |
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