Panels › Microbiology › Product code OZE · Class 2
Influenza A And Influenza B Multiplex Nucleic Acid Assay
Regulation 866.3980
1510(k)s in 12 months (21 all time)
1recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in OZE
| Company | 510(k)s | Recalls |
|---|---|---|
| Centers for Disease Control and Prevention | 10 | 1 |
| Abbott Diagnostics Scarborough, Inc. | 1 | 3 |
| Centers For Disease Control and Prevention (CDC) | 3 | 0 |
| Quidel Corp. | 3 | 0 |
| Alere Scarborough, Inc. | 1 | 0 |
| Center For Disease Control and Prevention (Cdc) | 1 | 0 |
| Indevr, Inc. | 1 | 0 |
| Luminex Corporation | 0 | 1 |
| Mesa Biotech, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2026 | Abbott Diagnostics Scarborough, Inc. Product Name: ID NOW" Influenza A & B 2
Model/Catalog Number: 427-000
Software Version: Not Applicable
Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique
Component: Open, Classified |
OZE | K171792 |
| Apr 15, 2025 | Abbott Diagnostics Scarborough, Inc. Brand Name: ID NOW Influenza A/B 2 24T
Product Name: ID NOW Influenza A/B 2 24T
Model/Catalog Number: 427-000
Software Version: N/A
Product Description: Influenza A And Influenza B Multiplex Nucleic A Open, Classified |
OZE | K232775 |
| Apr 15, 2025 | Abbott Diagnostics Scarborough, Inc. Brand Name: ID NOW Influenza A/B 2 24T
Product Name: ID NOW Influenza A/B 2 24T
Model/Catalog Number: 427-000
Software Version: N/A
Product Description: Influenza A And Influenza B Multiplex Nucleic A Open, Classified |
OZE | K232775 |
| Jun 27, 2024 | Centers For Disease Control and Prevention CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11 Terminated |
OZE | K200370 |
| Aug 15, 2019 | Luminex Corporation ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158 Open, Classified |
OZE | K161220 |
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