FastPack® Pro System 08000067, 08000067-R, 08000067-X
GUDID 00816467020372
RoHS Compliant 7-chamber FastPack System
QUALIGEN INC.
Chemiluminescent immunoassay analyser IVD, automated| 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.
| 00816467020396 - FastPack® IP System | 2024-10-07 |
| 00816467020402 - FastPack® IP System | 2024-10-07 |
| 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 |
Trademark Results [FastPack]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FASTPACK 98826028 not registered Live/Pending |
Acieta LLC 2024-10-29 |
 FASTPACK 98443566 not registered Live/Pending |
ISSC, Inc. 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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