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MTD
Hologic, Inc. · Model Amplified Mycobacterium Tuberculosis · UDI-DI 15420045500303
MWA
Prescription
0
510(k) clearances
1
Adverse events
2
Recalls
4
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-11-28 | Roche Molecular Systems, Inc. | The COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being used with AMPLILINK software version 3.3 series and COBAS TaqMan MTB Test Kits, both |
| 2004-07-07 | Roche Molecular Systems Inc | An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.
