FDA.reportPublic FDA data

FastPack® IP Free T4 Kit (30)

Primary DI
20816467020055
Brand
FastPack® IP Free T4 Kit (30)
Company
QUALIGEN INC.
Model
FT4 Immunoassay
Catalog number
25000043
Device description
30 Test Ported FT4 Immunoassay Kit
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CECRadioimmunoassay, Free Thyroxine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CECRadioimmunoassay, Free ThyroxineClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030329000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030329000FASTPACK FREE T4 IMMUNOASSAYQualigen, Inc.2003-07-03CEC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20816467020055PrimaryGS10
00816467020051Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081646702005520816467020055
00816467020051008164670200518164670200510816467020051

GMDN Terms#

Term, Definition table
TermDefinition
Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of free thyroxine (FT4) in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
959103565
Device count
30
Kit
true
Lot or batch
true
Expiration date on label
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
00816467020372FastPack® Pro System Pro System08000067, 08000067-R, 08000067-X2020-08-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590780982Access Free T4Beckman Coulter, Inc.CEC2024-03-12
00850049545990QMedix™Diagnostic Automation, Inc.CEC2024-02-02
04048474042665Free Thyroxine (fT4) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCEC2023-08-31
00894175000923AccuDiag ™Diagnostic Automation, Inc.CEC2023-06-14
07613336175071Elecsys FT4 IVRoche Diagnostics GmbHCEC2023-05-03
07613336172780Elecsys FT4 IVRoche Diagnostics GmbHCEC2023-05-02
06947145577971MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.CEC2022-08-02
06947145577988MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.CEC2022-08-02
00630414293851Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2020-12-12
00630414294292Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2020-12-12
00630414599144Atellica IM FT4 MCMSiemens Healthcare Diagnostics Inc.CEC2020-09-24
00630414293684Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2020-05-31
00630414294193Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2020-05-31
00840239042668Free Thyroxine (fT4) ELISADRG International IncCEC2019-06-10
00816870021713Free T4 AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CEC2019-02-11
00816870021720Free T4 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CEC2019-02-11
00816870021737Monobind AccuBind Free T4 ELISA Kit - 480 WellsMONOBIND, INC.CEC2019-02-11
00816870021744Free T4 AccuBind ELISA Test System - 960 WellsMONOBIND, INC.CEC2019-02-11
00816870023151Free T4 AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CEC2019-02-11
00816870023168Free T4 AccuLite CLIA Test System - 192 WellsMONOBIND, INC.CEC2019-02-11
00816870023175Free T4 AccuLite CLIA Test System - 480 WellsMONOBIND, INC.CEC2019-02-11
00816870023182Monobind AccuLite Free T4 CLIA Kit - 960 WellsMONOBIND, INC.CEC2019-02-11
00380740121822AlinityABBOTT IRELANDCEC2018-07-31
00380740121815AlinityABBOTT IRELANDCEC2018-05-31
00380740119799ARCHITECTABBOTT IRELANDCEC2018-05-14
00380740119805ARCHITECTABBOTT IRELANDCEC2018-05-14
00380740119812ARCHITECTABBOTT IRELANDCEC2018-05-14
08809317540382FREND Free T4NanoEnTek, Inc.CEC2018-05-04
00630414599120Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2018-02-06
00630414599137Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2018-02-06