GeneXpert® Xpress GX-IV Xpress
GUDID 07332940009243
GENEXPERT Xpress System
CEPHEID
Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory| Primary Device ID | 07332940009243 |
| NIH Device Record Key | 8f9a9840-9082-435a-93dd-34e7ec25ff27 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GeneXpert® Xpress |
| Version Model Number | GX-IV Xpress |
| Catalog Number | GX-IV Xpress |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com | |
| Phone | 18888383222 |
| techsupport@cepheid.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 45 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332940009243 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K171552
FDA Product Code
| OOI | Real Time Nucleic Acid Amplification System |
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 | 2023-10-30 |
| Device Publish Date | 2023-10-20 |
Devices Manufactured by CEPHEID
| 07332940008161 - GeneXpert® | 2024-02-26 Xpert® Xpress GBS |
| 07332940008581 - GeneXpert® | 2024-01-30 Xpert® Xpress CoV-2 plus |
| 07332940009243 - GeneXpert® Xpress | 2023-10-30GENEXPERT Xpress System |
| 07332940009243 - GeneXpert® Xpress | 2023-10-30 GENEXPERT Xpress System |
| 07332940008604 - GeneXpert® | 2023-10-03 Xpert Xpress CoV-2/Flu/RSV plus |
| 07332940007652 - Xpert® | 2022-08-08 GBS LB XC |
| 07332940007669 - Xpert® | 2022-08-08 GBS LB XC |
| 07332940007195 - GeneXpert® | 2022-05-20 Xpress System |
| 07332940006457 - Xpert® | 2022-05-11 Nasal Sample Collect Kit for Viruses |
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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