FDA.reportPublic FDA data

Atellica IM FT3

Primary DI
00630414293677
Brand
Atellica IM FT3
Company
Siemens Healthcare Diagnostics Inc.
Model
11206254
Catalog number
11206254
Device description
Free T3 (FT3) - Atellica IM - RGT 300T
Published
2020-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K991692000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991692000CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.1999-06-18CDP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414293677PrimaryGS10
00630414294186Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414293677006304142936776304142936770630414293677
00630414294186006304142941866304142941860630414294186

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store upright, Protect from light
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414124797ADVIA Centaur® Calibrator D10311569103115692014-09-24
00630414124933ADVIA Centaur® Systems, ACS:180® Systems Calibrator D10311576103115762014-09-24
00630414126319ADVIA Centaur® Systems, ACS 180® Systems AFP MCM10311625103116252014-09-24
00630414177335ADVIA Centaur® AFP10309980103099802014-09-24
00630414238791Atellica IM AFP11202257112022572018-11-14
00630414238807Atellica IM AFP11202258112022582018-11-14
00630414597720Atellica IM AFP MCM10995443109954432018-11-14
00630414279176ADVIA Chemistry UCFP11319151113191512020-03-06
00630414209845ADVIA® Chemistry MG Magnesium Reagents10341119103411192020-09-24
00630414474748ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents10309071103090712020-09-24
00630414508399ADVIA® Chemistry IP Inorganic Phosphorus Reagents10309503103095032020-09-24
00630414508429ADVIA® Chemistry MG Magnesium Reagents10309506103095062020-09-24
00630414561073ADVIA® Chemistry CHOL_2 Cholesterol_2 Reagent10376501103765012020-09-24
00630414561974ADVIA® Chemistry IRON_2 Iron 2 Reagents10377510103775102020-09-24
00630414279183ADVIA Chemistry UCFP Calibrator11319152113191522020-03-06
00842768013836Dimension Cardiac Troponin-I Flex reagent cartridge10444905104449052016-09-24
00842768013904Dimension Cardiac Troponin-I Flex reagent cartridge10444896104448962016-09-24
00630414008967ADVIA® Chemistry Enzyme 1 Calibrator10916057109160572016-09-24
00630414177328ADVIA Centaur® AFP10309979103099792014-09-24
00630414553153ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated10283343102833432016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336217702Elecsys T3Roche Diagnostics GmbHCDP2026-09-04
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