FDA.reportPublic FDA data

AIMSTEP THYROID SCREEN

Primary DI
00695684762209
Brand
AIMSTEP THYROID SCREEN
Company
GERMAINE LABORATORIES, INC
Model
76220
Device description
Cassette test for TSH in fingerstick whole blood
Published
2016-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JLWRadioimmunoassay, Thyroid-Stimulating Hormone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JLWRadioimmunoassay, Thyroid-Stimulating HormoneClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00695684762209PrimaryGS10
00695684762201Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00695684762209006956847622096956847622090695684762209
00695684762201006956847622016956847622010695684762201

GMDN Terms#

Term, Definition table
TermDefinition
Thyroid stimulating hormone (TSH) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of thyroid stimulating hormone (TSH) in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
176458115
Device count
20
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00695684744250AimStep Flu A&B Test Kit744252026-05-11
00695684773014AimStrip Tandem Lipid Profile and glucose measuring systemILM-0001A2020-03-13
00695684775506AimStrip Tandem blood glucose test stripsILM-0001A2020-03-13
00695684773106AimStrip Tandem Total Cholesterol Test StripsILM-0001A2020-03-13
00695684773120AimStrip Tandem Total Cholesterol Control SolutionILM-0001A2020-03-13
00695684774103AimStrip Tandem Total Triglycerides Test StripsILM-0001A2020-03-13
00695684774127AimStrip Tandem Total Triglycerides Control SolutionILM-0001A2020-03-13
00695684775124AimStrip Tandem Glucose control solutionILM-0001A2020-03-13
00695684423384AimScreen Fentanyl423382024-04-01
10695684423381AimScreen Fentanyl423382024-04-01
00695684893019Pregcolor Plus893012023-08-09
00695684971014Pregcolor Premium 97101PCP2023-08-09
00695684957018Mosie Baby Pregnancy Test957012019-10-21
00695684885304AIMSTRIP PREGNANCY885302016-04-11
00695684888305AIMSTRIP COMBO PREGNANCY888302016-04-27
00695684891015AccuHome Pregnancy Test891012016-04-11
00695684891022AccuHome Pregnancy Test891022016-04-11
00695684891404AccuHome Pregnancy Test891402016-04-11
00695684970253AIMSTEP PREGNANCY970252016-04-11
00695684970307AIMSTEP PREGNANCY970302016-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850049545044AccuDiag™Diagnostic Automation, Inc.JLW2024-11-14
00630414624488ADVIA Centaur TSH3-Ultra IISiemens Healthcare Diagnostics Inc.JLW2024-05-22
00630414624501ADVIA Centaur TSH3-Ultra IISiemens Healthcare Diagnostics Inc.JLW2024-05-22
00630414624518Atellica IM TSH3-Ultra IISiemens Healthcare Diagnostics Inc.JLW2024-05-22
00630414624525Atellica IM TSH3-Ultra IISiemens Healthcare Diagnostics Inc.JLW2024-05-22
00630414624532Atellica IM TSH3ULII MCM setSiemens Healthcare Diagnostics Inc.JLW2024-05-22
00630414624693Atellica IM TSH3-Ultra IISiemens Healthcare Diagnostics Inc.JLW2024-05-22
00630414624709ADVIA Centaur TSH3ULII MCM SETSiemens Healthcare Diagnostics Inc.JLW2024-05-22
00850054026262AccuDiag ™Diagnostic Automation, Inc.JLW2024-03-27
00850054026538QMedix™Diagnostic Automation, Inc.JLW2024-03-06
00850054026439QMedix™Diagnostic Automation, Inc.JLW2024-01-31
04048474052664Total Triiodothyronine (tT3) ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLW2023-09-01
04048474052831Thyrotropin (TSH) ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLW2023-09-01
04048474041118Thyrotropin (TSH) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungJLW2023-08-31
04048474017823Thyroid Stimulating Hormone (TSH) ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLW2023-08-26
04048474017908TSH (ultrasensitive) ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLW2023-08-26
00840239052834Thyrotropin (TSH) ELISADRG International IncJLW2023-08-25
15099590744373Access TSH (3rd IS)Beckman Coulter, Inc.JLW2022-12-31
07613336193693Elecsys TSHRoche Diagnostics GmbHJLW2022-11-18
06947145500016MAGLUMI 2000 TSHShenzhen New Industries Biomedical Engineering Co., Ltd.JLW2022-08-02
06947145500023MAGLUMI 2000 TSHShenzhen New Industries Biomedical Engineering Co., Ltd.JLW2022-08-02
00725609000618SPOTCHECKASTORIA-PACIFIC, INC.JLW2020-12-17
00630414293875Atellica IM TSH3-ULSiemens Healthcare Diagnostics Inc.JLW2020-12-12
00842768032417Dimension® EXL™/ Dimension Vista® MULTI 2 SDILSiemens Healthcare Diagnostics Inc.JLW2020-09-24
00630414293806Atellica IM TSH3-ULSiemens Healthcare Diagnostics Inc.JLW2020-05-31
00722066001950Rapid ResponseBTNX IncJLW2019-10-16
00850392007015BioCheck TSH EIA Test KitBIOCHECK, INC.JLW2019-10-08
00850392007039BioCheck U-TSH EIA Test KitBIOCHECK, INC.JLW2019-10-08
00840239014832Neonatal TSH ELISADRG International IncJLW2019-06-10
00840239041111Thyrotropin (TSH) ELISADRG International IncJLW2019-06-10