FDA.reportPublic FDA data

FastPack® Pro System

Primary DI
00816467020372
Brand
FastPack® Pro System
Company
QUALIGEN INC.
Model
Pro System
Catalog number
08000067, 08000067-R, 08000067-X
Device description
RoHS Compliant 7-chamber FastPack System
Published
2020-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJQColorimeter, Photometer, Spectrophotometer For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJQColorimeter, Photometer, Spectrophotometer For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816467020372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816467020372008164670203728164670203720816467020372

GMDN Terms#

Term, Definition table
TermDefinition
Chemiluminescent immunoassay analyser IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers (e.g., drug, hormone, microbial toxin) in a clinical specimen, using an immunological method that utilizes a chemiluminescent detection system together with sample processing, data processing and/or data display software. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-770-6127systemsupport@qualigeninc.com

Regulatory Flags#

DUNS number
959103565
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816467020396FastPack® IP SystemIP System08000043-A, 08000043-AR2024-09-27
00816467020402FastPack® IP SystemIP System08000043-X22024-09-27
10816467020126FastPack® IP hCG Kit (30)hCG Immunoassay250000442016-09-16
00816467020105Calibrator Kit – hCGhCG Cal250000352016-09-16
00816467020112FastPack® IP hCG Diluent Kit (25)hCG Diluent250000362016-09-16
10816467020034FastPack® Testo Kit (50)Testo Immunoassay250000092016-09-16
20816467020031FastPack® IP Testo Kit (30)Testo Immunoassay250000412016-09-16
30816467020038FastPack® IP Testo Kit (90)Testo Immunoassay250000582017-09-14
00816467020044Calibrator Kit - TestosteroneTesto Cal250000142016-09-16
00816467020136FastPack® Control KitMulti-Analyte Controls250000562016-09-16
00816467020006FastPack® IP SystemIP System08000043, 08000043-R, 08000043-X2016-09-16
00816467020334FastPack® IP SystemIP System08000043-C, 08000043-CR2016-09-16
10816467020386FastPack SARS-CoV-2 IgGSARS-CoV-2 IgG Immunoassay250000852020-08-05
00816467020389FastPack SARS-CoV-2 IgGSARS-CoV-2 IgG Immunoassay250000852020-08-05
10816467020010FastPack® Total PSA Kit (50)TPSA Immunoassay250000012016-09-16
20816467020017FastPack® IP Total PSA Kit (30)TPSA Immunoassay250000402016-09-16
30816467020014FastPack® IP Total PSA Kit (90)TPSA Immunoassay250000572017-09-14
00816467020020Calibrator Kit - PSATPSA Cal250000022016-09-16
00816467020075Method Verification Kit - PSATPSA Verifier250000172016-09-16
00816467020167Control Kit - PSAPSA Controls250000032016-09-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860011967750ZELLECHEM 200STERILE SAFEQUIP & CHEMICALS LLPJJQ2024-10-01
00816467020396FastPack® IP SystemQUALIGEN INC.JJQ2024-09-27
00816467020402FastPack® IP SystemQUALIGEN INC.JJQ2024-09-27
00816870020006NeoLumax CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020013LuMatic CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020051NeoEldex ELISA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020068PrisMatic ELISA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020075Autoplex G1 ELISA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020082Autoplex G2 ELISA + CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870024448Autoplex G3 ELISA + CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
07290016923063Auto Sampler (for BreathID Hp Lab System)MERIDIAN BIOSCIENCE ISRAEL LTDJJQ2024-07-22
07290016923384BreathID Hp Lab DeviceMERIDIAN BIOSCIENCE ISRAEL LTDJJQ2024-07-22
07290016923391BreathID Hp Lab Device (WIN)MERIDIAN BIOSCIENCE ISRAEL LTDJJQ2024-07-22
00860011967743ZELLECHEM-PROSTERILE SAFEQUIP & CHEMICALS LLPJJQ2024-07-09
04048474052527DRG:HYBRiD.XL®DRG Instruments Gesellschaft mit beschränkter HaftungJJQ2023-09-02
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10810138822705EndocatorEndo Direct LLCJJQ2023-07-16
09120052071184SUNRISETecan Austria GmbHJJQ2023-07-06
09120052071191SUNRISE-RC/ST EVOLYZERTecan Austria GmbHJJQ2023-07-06
09120052071207SUNRISE-RC/TW EVOLYZERTecan Austria GmbHJJQ2023-07-06
09120052071214SUNRISE-RC/6F EVOLYZERTecan Austria GmbHJJQ2023-07-06
06936895300151BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
06936895300212BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
06936895300229BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
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06936895300243BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
00850229007010StatFaxAWARENESS TECHNOLOGY, INCORPORATEDJJQ2023-06-05