FDA UDI
In Commercial Distribution
🇺🇸 United States
VisuCon-F Frozen Coag Screen ABN
DI: 10629009081819
·
Model: FCSAB0181
·
Affinity Biologicals Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
81
Basic Information
- Brand Name
- VisuCon-F Frozen Coag Screen ABN
- Primary DI
- 10629009081819
- Version / Model
- FCSAB0181
- Company Name
- Affinity Biologicals Inc
- Labeler DUNS
- 249373515
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 81
- Record Status
- Published
- Publish Date
- 2017-04-28
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- cb09db9c-1b34-4cc0-80d4-d93807499400
Device Description
Intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT), in the mid-level abnormal range.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| GGN | Plasma, Coagulation Control | Hematology | 864.5425 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30590 | Multiple coagulation factor IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10629009081819 | GS1 | ||||
| Unit of Use | 10629009080010 | GS1 | ||||
| Previous | 16290090081817 | GS1 |
Customer Contacts
- Phone
- 1-800-903-6020
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K110432 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at or below -60°C