BD MAX™ GBS
Catalogue number 441772, listed by Becton, Dickinson AND Company, United States, under Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
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 | Becton, Dickinson AND Company, 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 | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K111860 |
| Record published | 2016-05-19 |
| Record revised | 2024-08-30 (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 |
| Storage | Storage environment temperature 2 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 441772 | In distribution |
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 |
| AmpliVue | Quidel Corp. | 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 |
Showing 12 of 19. All products under Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | 510(k) number | 2024-12-19 | Class II | Under Investigation by firm | Potential for signal drift in specific lots of BD PCR Cartridges. | 516,435 units | |
| Becton, Dickinson & Co. | 510(k) number | 2013-05-31 | Class III | Component change control | Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled. | 71 instruments | 2013-08-19 |
| Becton, Dickinson & Co. | 510(k) number | 2012-12-11 | Class II | Process control | Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs. | 27 boxes/648 cartridges | 2013-07-22 |
| Becton, Dickinson & Co. | 510(k) number | 2012-09-18 | Class II | Device Design | Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results. | 86 Instruments | 2013-02-04 |
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.