Definition: A Nucleic Acid Amplification Assay System (including Probes, Other Reagents, And Instrumentation) Is An Aid In The Identification Of Group B Streptococci From Pre-partum And Intra-partum Women To Establish Colonization Status.
| Device Type ID | 3512 |
| Device Name | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| Regulation Description | Streptococcus Spp. Serological Reagents. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 866.3740 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NJR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3512 |
| Device | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| Product Code | NJR |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Streptococcus Spp. Serological Reagents. |
| CFR Regulation Number | 866.3740 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DIASORIN MOLECULAR LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GREAT BASIN CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LUMINEX CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEUMODX MOLECULAR | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QUIDEL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QUIDEL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 1 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biomerieux Inc | II | Dec-29-2015 |