FDA UDI
In Commercial Distribution
🇺🇸 United States
PreciControl Release Anti-CMV
DI: 07613336182987
·
Model: 09366679190
·
Roche Diagnostics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PreciControl Release Anti-CMV
- Primary DI
- 07613336182987
- Version / Model
- 09366679190
- Catalog Number
- 09366679190
- Company Name
- Roche Diagnostics GmbH
- Labeler DUNS
- 315028860
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-05
- Public Version
- 1
- Public Version Date
- 2023-12-13
- Public Version Status
- New
- Public Device Record Key
- 5fea5c0c-8f60-47e2-b331-a2e3f925c560
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MZE | Test, donor, CMV | Unknown | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49721 | Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody avidity index IVD, control | A material which is used to verify the performance of an assay intended to be used for the determination of the avidity index of immunoglobulin G (IgG) antibodies to cytomegalovirus (CMV) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613336182987 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK230840 | 0 |