FastPack® Pro System 08000067, 08000067-R, 08000067-X
GUDID 00816467020372
RoHS Compliant 7-chamber FastPack System
QUALIGEN INC.
Chemiluminescent immunoassay analyser IVD, automated Chemiluminescent immunoassay analyser IVD, automated Chemiluminescent immunoassay analyser IVD, automated Chemiluminescent immunoassay analyser IVD, automated Chemiluminescent immunoassay analyser IVD, automated Chemiluminescent immunoassay analyser IVD, automated Chemiluminescent immunoassay analyser IVD, automated Chemiluminescent immunoassay analyser IVD, automated Chemiluminescent immunoassay analyser IVD, automated Chemiluminescent immunoassay analyser IVD, automated Chemiluminescent immunoassay analyser IVD, automated Chemiluminescent immunoassay analyser IVD, automated Chemiluminescent immunoassay analyser IVD, automated Chemiluminescent immunoassay analyser IVD, automated Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD| Primary Device ID | 00816467020372 |
| NIH Device Record Key | 5851e9ca-be6f-4193-96ce-bc1e228abb2e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FastPack® Pro System |
| Version Model Number | Pro System |
| Catalog Number | 08000067, 08000067-R, 08000067-X |
| Company DUNS | 959103565 |
| Company Name | QUALIGEN INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816467020372 [Primary] |
FDA Product Code
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
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 | 2020-08-13 |
| Device Publish Date | 2020-08-05 |
Devices Manufactured by QUALIGEN INC.
| 10816467020126 - FastPack® IP hCG Kit (30) | 2023-07-06 30 Test Ported hCG Immunoassay Kit |
| 10816467020034 - FastPack® Testo Kit (50) | 2023-05-03 50 Test Non-Ported Testo Immunoassay Kit |
| 00816467020372 - FastPack® Pro System | 2020-08-13RoHS Compliant 7-chamber FastPack System |
| 00816467020372 - FastPack® Pro System | 2020-08-13 RoHS Compliant 7-chamber FastPack System |
| 00816467020389 - FastPack SARS-CoV-2 IgG | 2020-08-13 90 Test Kit SARS-CoV-2 IgG Immunoassay |
| 10816467020010 - FastPack® Total PSA Kit (50) | 2020-02-06 50 Test Non-Ported TPSA Immunoassay Kit |
| 20816467020017 - FastPack® IP Total PSA Kit (30) | 2020-02-06 30 Test Ported TPSA Immunoassay Kit |
| 30816467020014 - FastPack® IP Total PSA Kit (90) | 2020-02-06 90 Test Ported TPSA Immunoassay Kit |
| 00816467020020 - Calibrator Kit - PSA | 2020-02-06 |
Trademark Results [FastPack]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FASTPACK 98443566 not registered Live/Pending |
2024-03-11 |
 FASTPACK 90474832 not registered Live/Pending |
Acieta LLC 2021-01-19 |
 FASTPACK 90320908 not registered Live/Pending |
Squeegee Bros Inc. 2020-11-16 |
 FASTPACK 88199317 5798966 Live/Registered |
KENT PRECISION FOODS GROUP, INC. 2018-11-19 |
 FASTPACK 85234933 4041065 Live/Registered |
VITEC HOLDINGS ITALIA SRL 2011-02-04 |
 FASTPACK 78487452 3067650 Live/Registered |
Target Brands, Inc. 2004-09-22 |
 FASTPACK 76285908 not registered Dead/Abandoned |
Agilera, Inc. 2001-07-17 |
 FASTPACK 75399007 2412780 Live/Registered |
QUALIGEN, INC. 1997-12-02 |
 FASTPACK 74633834 not registered Dead/Abandoned |
Rockport Company, Inc. 1995-02-13 |
 FASTPACK 73488093 1328557 Live/Registered |
Color & Design, Inc. 1984-07-02 |
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