GeneXpert® XPRSGBS-10
GUDID 07332940008161
Xpert® Xpress GBS
CEPHEID
Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)| Primary Device ID | 07332940008161 |
| NIH Device Record Key | 95724a0a-2ae9-4f19-ac18-eeb1ded233ee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GeneXpert® |
| Version Model Number | XPRSGBS-10 |
| Catalog Number | XPRSGBS-10 |
| Company DUNS | 956711444 |
| Company Name | CEPHEID |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332940008161 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K222638
FDA Product Code
| NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-26 |
| Device Publish Date | 2024-02-16 |
On-Brand Devices [GeneXpert®]
| 07332940007720 | Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infi |
| 07332940007713 | Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infi |
| 07332940007706 | XPERT, GENEXPERT DX SYSTEM |
| 07332940007690 | XPERT, GENEXPERT DX SYSTEM |
| 07332940007683 | XPERT, GENEXPERT DX SYSTEM |
| 07332940007195 | Xpress System |
| 07332940008604 | Xpert Xpress CoV-2/Flu/RSV plus |
| 07332940008581 | Xpert® Xpress CoV-2 plus |
| 07332940008161 | Xpert® Xpress GBS |
| 07332940009366 | Xpert® HCV |
Trademark Results [GeneXpert]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GENEXPERT 77328654 4026395 Live/Registered |
Cepheid 2007-11-13 |
 GENEXPERT 75771218 2534624 Live/Registered |
Cepheid 1999-08-05 |
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