PIFA PLUSS® PF4 Rapid Assay 4001101
GUDID 00708872615124
A collection of reagents and other associated materials intended to be used for the qualitative detection of total antibodies to platelet factor 4-heparin complex in a clinical specimen within a short period, relative to standard laboratory testing procedures, using PIFA PLUSS® PF4 Rapid Assay.
AKERS BIOSCIENCES, INC.
Platelet factor 4-heparin complex total antibody IVD, kit, agglutination, rapid| Primary Device ID | 00708872615124 |
| NIH Device Record Key | 59a94c8d-76a8-44c1-bdb4-075a6fb862ec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PIFA PLUSS® PF4 Rapid Assay |
| Version Model Number | 4001101 |
| Catalog Number | 4001101 |
| Company DUNS | 611245549 |
| Company Name | AKERS BIOSCIENCES, INC. |
| Device Count | 6 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 8568488698 |
| mrodriguez@akers.com | |
| Phone | 8568488698 |
| mrodriguez@akers.com | |
| Phone | 8568488698 |
| mrodriguez@akers.com | |
| Phone | 8568488698 |
| mrodriguez@akers.com | |
| Phone | 8568488698 |
| mrodriguez@akers.com | |
| Phone | 8568488698 |
| mrodriguez@akers.com | |
| Phone | 8568488698 |
| mrodriguez@akers.com | |
| Phone | 8568488698 |
| mrodriguez@akers.com | |
| Phone | 8568488698 |
| mrodriguez@akers.com | |
| Phone | 8568488698 |
| mrodriguez@akers.com | |
| Phone | 8568488698 |
| mrodriguez@akers.com | |
| Phone | 8568488698 |
| mrodriguez@akers.com | |
| Phone | 8568488698 |
| mrodriguez@akers.com | |
| Phone | 8568488698 |
| mrodriguez@akers.com | |
| Phone | 8568488698 |
| mrodriguez@akers.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00708872000042 [Primary] |
| GS1 | 00708872615124 [Primary] |
| GS1 | 01708872000042 [Unit of Use] |
| GS1 | 01708872615124 [Unit of Use] |
FDA Product Code
| LCO | Platelet Factor 4 Radioimmunoassay |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-07-05 |
| Device Publish Date | 2018-06-04 |
Devices Manufactured by AKERS BIOSCIENCES, INC.
| 00708872000004 - Heparin/PF4 Antibody Serum Panel | 2018-07-06 The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use as a serum QC control to monitor and |
| 00708872000011 - Heparin/PF4 Antibody Serum Panel | 2018-07-06 The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use as a serum QC control to monitor and |
| 00708872615124 - PIFA PLUSS® PF4 Rapid Assay | 2018-07-05A collection of reagents and other associated materials intended to be used for the qualitative detection of total antibodies to platelet factor 4-heparin complex in a clinical specimen within a short period, relative to standard laboratory testing procedures, using PIFA PLUSS® PF4 Rapid Assay. |
| 00708872615124 - PIFA PLUSS® PF4 Rapid Assay | 2018-07-05 A collection of reagents and other associated materials intended to be used for the qualitative detection of total antibodies to |
| 00708872615123 - PIFA® Heparin/PF4 Rapid Assay | 2018-03-29 A collection of reagents and other associated materials intended to be used for the qualitative detection of total antibodies to |
Trademark Results [PIFA PLUSS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PIFA PLUSS 85485943 4227663 Live/Registered |
Akers Biosciences, Inc. 2011-12-02 |
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