FDA.reportPublic FDA data

IMMULITE® Systems TBG CONTROL

Primary DI
00630414953298
Brand
IMMULITE® Systems TBG CONTROL
Company
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Model
10385244
Catalog number
LTBCM
Device description
TBG - IMMULITE - CTL - 2x2.0mL
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CEERadioimmunoassay, thyroxine-binding globulin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEERadioimmunoassay, Thyroxine-Binding GlobulinClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K950072000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K950072000IMMULITE(R) TBGDiagnostic Products Corp.1995-04-03JJX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414953298PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414953298006304149532986304149532980630414953298

GMDN Terms#

Term, Definition table
TermDefinition
Thyroxine binding globulin (TBG) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of thyroxine binding globulin (TBG) in a clinical specimen.

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
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
00630414245362ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201760112017602026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816870021263N-TBG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CEE2019-02-11
00816870021270N-TBG AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CEE2019-02-11
00816870021287N-TBG AccuBind ELISA Test System - 480 WellsMONOBIND, INC.CEE2019-02-11
00816870021751Monobind AccuBind TBG ELISA Kit - 96 WellsMONOBIND, INC.CEE2019-02-11
00816870023199Monobind AccuLite TBG CLIA Kit - 96 WellsMONOBIND, INC.CEE2019-02-11
00630414954271IMMULITE® 2000 Systems TGB TBG Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCEE2016-09-24
00630414962078IMMULITE® 2000 Systems TBGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCEE2016-09-24
00630414962207IMMULITE® 2000 Systems TU Thyroid UptakeSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCEE2016-09-24
00630414964652IMMULITE®/IMMULITE® 1000 Systems TBGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCEE2016-09-24
00630414978222IMMULITE®/IMMULITE® 1000 Systems TU Thyroid UptakeSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCEE2016-09-24