AmpliVue
AmpliVue GBS Assay
2manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
All of them in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | Nantong | Jiangsu | Manufacturer | 11 |
| Suzhou Tianlong Biotechnology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 5 |
Record
| Listed by | Quidel Corp., United States |
|---|---|
| FDA product code | NJR |
| Device type | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3740 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2018-08-30 |
| Record revised | 2025-05-23 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2020-07-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GBS Assay | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SmartCycler Dx System | Cepheid | 16 |
| Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR) | Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | 3 |
| Panther Fusion® | Hologic, Inc. | 3 |
| Xpert GBS LB | Cepheid | 2 |
| Xpert® | Cepheid | 2 |
| Alethia™ Group B Streptococcus | Meridian Bioscience, Inc. | 1 |
| Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EP | Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | 1 |
| Revogene GBS LB | Meridian Bioscience, Inc. | 1 |
| NeuMoDxTM GBS Test Strip | Neumodx Molecular, Inc. | 1 |
| Solana | Diagnostic Hybrids, Inc. | 1 |
| Aries® GBS Assay | Luminex Corporation | 1 |
| Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR) | Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | 1 |
Showing 12 of 19. All products under Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173250 | 2017-12-21 |
| K133503 | 2013-12-20 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.