FDA UDI
In Commercial Distribution
🇺🇸 United States
cobas® HBV Quantitative nucleic acid test for use on the cobas® 6800/8800 System
DI: 00875197004885
·
Model: 07000979190
·
Roche Diagnostics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- cobas® HBV Quantitative nucleic acid test for use on the cobas® 6800/8800 System
- Primary DI
- 00875197004885
- Version / Model
- 07000979190
- Catalog Number
- 07000979190
- Company Name
- Roche Diagnostics GmbH
- Labeler DUNS
- 315028860
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-12-04
- Public Version
- 4
- Public Version Date
- 2021-04-21
- Public Version Status
- Update
- Public Device Record Key
- 98efb26a-312b-41e7-8a82-3266ee79cd1e
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MKT | Hepatitis Viral B DNA Detection | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48307 | Hepatitis B 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 B virus nucleic acid in a clinical specimen, using a nucleic acid technique (NAT). The nucleic acids detected may include genes encoding the core protein, surface antigen, e-antigen, and/or other genome regions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00875197004885 | GS1 |