akers.com
akersbio.comBREATHSCN PRO
Akers Biosciences, Inc.
AKERS BIOSCIENCES, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2247413 | 1000121922 | AKERS BIOSCIENCES, INC. | 1 | N | 2020-04-25 | 201 Grove Rd West Deptford NJ US 08086 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00708872000004 | Heparin/PF4 Antibody Serum Panel - 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. | 8568488698 | mrodriguez@akersbio.com |
| 00708872000011 | Heparin/PF4 Antibody Serum Panel - 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. | 8568488698 | mrodriguez@akersbio.com |
| 00708872000042 | PIFA PLUSS® PF4 Rapid Assay - 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. | 8568488698 | mrodriguez@akers.com |
| 00708872615123 | PIFA® Heparin/PF4 Rapid Assay - 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® Heparin/PF4 Rapid Assay. | 856-848-8698 | sandrelczyk@akersbio.com |
| 00708872615124 | PIFA PLUSS® PF4 Rapid Assay - 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. | 8568488698 | mrodriguez@akers.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 44856 | 1711732469 | K880723 | DIMENSION WHOLE BLOOD CHOLESTEROL | CHH | 1988-11-08 |
| 44856 | 1882378515 | K102338 | BREATHSCN PRO | DJZ | 2011-01-12 |
| 44856 | 1175447235 | K062971 | BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS | DJZ | 2006-12-18 |
| 44856 | 2020733125 | K060761 | BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS | DJZ | 2006-04-28 |
| 44856 | 1513201622 | K052697 | HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL | GGN | 2006-01-04 |
| 44856 | 1887152003 | K050338 | MODIFICATION TO: INSTAREAD LITHIUM SYSTEM | JIH | 2005-03-04 |
| 44856 | 1088680100 | K040293 | HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY | LCO | 2004-05-28 |
| 44856 | 1519298413 | K030815 | AKERS LABORATORIES INC. BLOOD CELL SEPARATOR | JKA | 2003-09-17 |
| 44856 | 1634755956 |
Product Codes Associated With Registrations#
PMN#
BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS
Akers Biosciences, Inc.
BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS
Akers Biosciences, Inc.
HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL
Akers Biosciences, Inc.
MODIFICATION TO: INSTAREAD LITHIUM SYSTEM
Akers Biosciences, Inc.
GUDID#
PIFA PLUSS® PF4 Rapid Assay - 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.
2018-06-04
PIFA® Heparin/PF4 Rapid Assay - 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® Heparin/PF4 Rapid Assay.
2016-09-24
Heparin/PF4 Antibody Serum Panel - 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.
2018-03-05
Heparin/PF4 Antibody Serum Panel - 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.
2018-03-05
PIFA PLUSS® PF4 Rapid Assay - 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.
2018-06-04