FDA UDI
In Commercial Distribution
🇺🇸 United States
cobas® HIV-1/HIV- 2 192T
DI: 00875197006483
·
Model: 09040536190
·
Roche Molecular Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- cobas® HIV-1/HIV- 2 192T
- Primary DI
- 00875197006483
- Version / Model
- 09040536190
- Catalog Number
- 09040536190
- Company Name
- Roche Molecular Systems, Inc.
- Labeler DUNS
- 071674100
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-14
- Public Version
- 1
- Public Version Date
- 2021-12-22
- Public Version Status
- New
- Public Device Record Key
- 5f5e3462-3be7-46f3-9923-eece10befffd
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MZF | Test, HIV detection | Microbiology | 866.3956 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48443 | HIV1/HIV2 nucleic acid IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00875197006483 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BP190360 | 0 |