FDA UDI
In Commercial Distribution
🇺🇸 United States
vW Select Kit (Ristocetin Cofactor)
DI: G0561067301
·
Model: 106730
·
Bio/Data Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- vW Select Kit (Ristocetin Cofactor)
- Primary DI
- G0561067301
- Version / Model
- 106730
- Catalog Number
- 106730
- Company Name
- Bio/Data Corporation
- Labeler DUNS
- 051392959
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-23
- Public Version
- 1
- Public Version Date
- 2022-03-31
- Public Version Status
- New
- Public Device Record Key
- 2d47ee02-83d8-4dad-b959-aaf521ad7860
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | Hematology | 864.7290 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56081 | von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of von Willebrand factor:ristocetin cofactor complex activity (vWF:RCO) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G0561067301 | HIBCC |