FDA UDI
In Commercial Distribution
🇺🇸 United States
HemosIL von Willebrand Factor Antigen
DI: 08426950041177
·
Model: 00020002300
·
INSTRUMENTATION LABORATORY COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HemosIL von Willebrand Factor Antigen
- Primary DI
- 08426950041177
- Version / Model
- 00020002300
- Catalog Number
- 00020002300
- Company Name
- INSTRUMENTATION LABORATORY COMPANY
- Labeler DUNS
- 557223252
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 9
- Public Version Date
- 2023-10-30
- Public Version Status
- Update
- Public Device Record Key
- db3fdfa3-326a-4797-8fbe-8fd40bbf8c5f
Device Description
HemosIL von Willebrand Factor Antigen
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 |
|---|---|---|---|---|
| GGP | TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY | Hematology | 864.7290 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56026 | Coagulation factor VIII-associated antigen IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the quantitative measurement of coagulation factor VIII-associated antigen, also known as von Willebrand antigen, in a clinical specimen using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08426950041177 | GS1 |
Customer Contacts
- Phone
- 1-800-678-0710
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.