FDA UDI
In Commercial Distribution
🇺🇸 United States
GeneXpert®
DI: 07332940009366
·
Model: GXHCV-10
·
CEPHEID
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- GeneXpert®
- Primary DI
- 07332940009366
- Version / Model
- GXHCV-10
- Catalog Number
- GXHCV-10
- Company Name
- CEPHEID
- Labeler DUNS
- 956711444
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-22
- Public Version
- 1
- Public Version Date
- 2024-07-30
- Public Version Status
- New
- Public Device Record Key
- ec56e36d-5584-4744-9c2a-1832e7a8e74a
Device Description
Xpert® HCV
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| SBP | Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test | Microbiology | 866.3171 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48374 | Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Hepatitis C virus nucleic acid in a clinical specimen, using a nucleic acid technique (NAT). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07332940009366 | GS1 |
Customer Contacts
- Phone
- 18888383222
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 28 Degrees Celsius