FDA UDI
In Commercial Distribution
🇺🇸 United States
cobas Factor II and Factor V Test
DI: 00875197005998
·
Model: 07948352190
·
Roche Molecular Systems, Inc.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- cobas Factor II and Factor V Test
- Primary DI
- 00875197005998
- Version / Model
- 07948352190
- Catalog Number
- 07948352190
- Company Name
- Roche Molecular Systems, Inc.
- Labeler DUNS
- 071674100
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-14
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- d8becc8c-fb0b-40ea-99c8-af292e327364
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| NPR | TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR | Hematology | 864.7280 | 2 |
| NPQ | TEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR | Hematology | 864.7280 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59586 | Inherited thrombophilia IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict inherited thrombophilia, which may be associated with, but not limited to, the prothrombin 20,210 mutation and/or the Factor V Leiden mutation (activated protein C resistance), using a nucleic acid technique (NAT). | No | Active |
| 58952 | Coagulation factor II (prothrombin) mutation IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict the coagulation factor II (prothrombin) G20210A mutation associated with venous thrombosis, using a nucleic acid technique (NAT). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00875197005998 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172913 | 000 |