Panels › Microbiology › Product code PMN · Class 2
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Regulation 866.3920
6510(k)s in 12 months (33 all time)
0recalls in 12 months (4 all time)
1recalls that name a 510(k)
Top companies in PMN
| Company | 510(k)s | Recalls |
|---|---|---|
| Maine Molecular Quality Controls, Inc. | 14 | 0 |
| Microbiologics, Inc. | 8 | 4 |
| Streck | 6 | 0 |
| Bio-Rad Laboratories | 2 | 0 |
| Biofire Defense, LLC | 2 | 0 |
| Zeptometrix | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2019 | Microbiologics Inc Cepheid Xpert C. difficile/Epi Control Panel Open, Classified |
PMN | K190463 |
| Apr 9, 2019 | Microbiologics Inc Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233
Product Usage:
On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direc Open, Classified |
PMN | None listed |
| Apr 9, 2019 | Microbiologics Inc Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226
Product Usage:
On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US Open, Classified |
PMN | None listed |
| Mar 7, 2019 | Microbiologics Inc Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use Terminated |
PMN | None listed |
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