FDA UDI
In Commercial Distribution
🇺🇸 United States
Heparin/PF4 Antibody Serum Panel
DI: 00708872000011
·
Model: 4036028
·
AKERS BIOSCIENCES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- Heparin/PF4 Antibody Serum Panel
- Primary DI
- 00708872000011
- Version / Model
- 4036028
- Catalog Number
- 4036028
- Company Name
- AKERS BIOSCIENCES, INC.
- Labeler DUNS
- 611245549
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2018-03-05
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- 02b7de8e-66e6-4d50-983b-4754dc9a622f
Device Description
The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use as a serum QC control to monitor and evaluate precision and accuracy of the (qualitative) PIFA® Heparin/PF4 Rapid Assay. Included are both confirmed positive and negative control panel members.
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 |
|---|---|---|---|---|
| 60534 | Platelet factor 4-heparin complex antibody IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of antibodies to platelet factor 4-heparin complex in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00708872000011 | GS1 | ||||
| Unit of Use | 01708872000011 | GS1 |
Customer Contacts
- Phone
- 8568488698
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K052697 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – -70 Degrees Celsius