FDA.reportPublic FDA data

IMMULITE®/IMMULITE® 1000 Systems TSH Third Generation TSH

Primary DI
00630414964775
Brand
IMMULITE®/IMMULITE® 1000 Systems TSH Third Generation TSH
Company
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Model
10381627
Catalog number
LKTS5
Device description
TSH - IMMULITE - RGT - 500 Tests
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CDPRADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDPRadioimmunoassay, Total TriiodothyronineClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K940006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K940006000IMMULITE THIRD GENERATION (MODIFICATION)Diagnostic Products Corp.1994-12-19JLW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414964775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414964775006304149647756304149647750630414964775

GMDN Terms#

Term, Definition table
TermDefinition
Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of thyroid stimulating hormone (TSH) 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)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
296822794
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414964041IMMULITE®/IMMULITE® 1000 Systems IG1 IGF-110381403103814032020-09-24
00630414965017IMMULITE®/IMMULITE® 1000 Systems SUBS10385394LSUBX2020-09-24
00630414961125IMMULITE® 2000 Systems CEA10380995L2KCE62016-09-24
00630414964980IMMULITE®/IMMULITE® 1000 Systems RPT Turbo Intact PTH10381430LSKPTZ2016-09-24
00630414970110IMMULITE®/IMMULITE® 1000 Systems T4 Total T410381635LKT452016-09-24
00630414972923IMMULITE®2000 Systems Diluent Tube Caps10385211L2ZC2020-09-24
00630414965734IMMULITE® 2000 Systems Allergen Tube Caps10282837L2ATC2020-09-24
00630414965741IMMULITE® 2000 Systems Allergen Tubes10282849L2ATS22020-09-24
00630414973159IMMULITE® 2000 Systems Diluent Tubes10385210L2ZT2020-09-24
00630414974064IMMULITE® 2000 Systems Microsampling Tube Caps10385205LSMC2020-09-24
00630414954547IMMULITE® 2000 Systems Reaction Tubes10385206LRXT2016-09-24
00630414973937IMMULITE® 2000 Systems Microsampling Tubes10385207LMST2016-09-24
00630414982403IMMULITE® 2000 XPi Sample Nesting Cups103741789052882016-09-24
00630414982410IMMULITE® 2000 Xpi Sample Nesting Cups103741799052892016-09-24
00630414961538IMMULITE® 2000 Systems IGF-110381448L2KGF22020-09-24
00630414245317Atellica IM Anti-Thyroglobulin II (aTgII)11201759112017592026-02-04
00630414245324Atellica IM Anti-Thyroglobulin II (aTgII)11201761112017612026-02-04
00630414245331Atellica IM aTgII Quality Control (aTgII QC)11201752112017522026-02-04
00630414245348Atellica IM aTgII Master Curve Material (aTgII MCM)11201751112017512026-02-04
00630414245355ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201758112017582026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054026446AccuDiag™ T3 ELISA KitDiagnostic Automation, Inc.CDP2026-03-02
14562185395447CL AIA-PACK T3 TEST CUPTOSOH CORPORATIONCDP2025-09-01
24562185395444CL AIA-PACK T3 TEST CUPTOSOH CORPORATIONCDP2025-09-01
00840239023858Free Triiodothyronine (fT3) ELISADRG International IncCDP2024-09-23
00840239038012Free T3 ELISADRG International IncCDP2024-09-23
00840239053565T3 freeDRG International IncCDP2024-09-23
04048474023855Free Triiodothyronine (fT3) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDP2024-09-23
04048474038019Free T3 ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDP2024-09-23
04048474053562T3 freeDRG Instruments Gesellschaft mit beschränkter HaftungCDP2024-09-23
00840239056979T-3DRG International IncCDP2024-08-13
04048474056976T-3DRG Instruments Gesellschaft mit beschränkter HaftungCDP2024-08-13
B24220TT3HUE011Total Triiodothyronine (Total T3) ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CDP2024-07-22
04048474052756Total Triiodothyronine (tT3) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDP2023-09-01
04048474052770Free Triiodothyronine (fT3) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDP2023-09-01
04048474041071Free Triiodothyronine (fT3) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungCDP2023-08-31
04048474045697T3 Total ELISA DRG Instruments Gesellschaft mit beschränkter HaftungCDP2023-08-31
04048474017809Triiodothyronine (T3) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDP2023-08-29
00840239045690T3 Total ELISA DRG International IncCDP2023-08-25
00840239052759Total Triiodothyronine (tT3) ELISADRG International IncCDP2023-08-25
15099590201661Access Free T3Beckman Coulter, Inc.CDP2023-06-26
15099590227210Access Total T3Beckman Coulter, Inc.CDP2023-06-26
00894175000886AccuDiag ™Diagnostic Automation, Inc.CDP2023-06-14
00850049545976QmedixDiagnostic Automation, Inc.CDP2023-06-13
10758750033782VITROSORTHO CLINICAL DIAGNOSTICSCDP2023-03-28
04049016139232Free Triiodothyronine (FT3) ELISAEUROIMMUN Medizinische Labordiagnostika AGCDP2022-12-08
06925912718505iFlash-T3Shenzhen YHLO Biotech Co., Ltd.CDP2022-10-26
07613336171578Elecsys FT3 IIIRoche Diagnostics GmbHCDP2021-10-02
07613336171585Elecsys FT3 IIIRoche Diagnostics GmbHCDP2021-10-02
07613336171646Elecsys T3Roche Diagnostics GmbHCDP2021-08-13
07613336171653Elecsys T3Roche Diagnostics GmbHCDP2021-08-13