FDA.reportPublic FDA data

Total T4 MAb 125I RIA Kit

Primary DI
00817830022474
Brand
Total T4 MAb 125I RIA Kit
Company
MP BIOMEDICALS, LLC
Model
06B254029
Catalog number
06B254029
Device description
Radioimmunoassay for the quantitative determination of Total Thyroxine (T4) MAb in human plasma or serum.
Published
2016-10-20
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
CDXRadioimmunoassay, total thyroxine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDXRadioimmunoassay, Total ThyroxineClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K904816000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K904816000THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMMBd Becton Dickinson Vacutainer Systems Preanalytic1991-01-17CDX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817830022474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817830022474008178300224748178300224740817830022474

GMDN Terms#

Term, Definition table
TermDefinition
Total thyroxine (TT4) IVD, kit, radioimmunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of total thyroxine (TT4) in a clinical specimen, using a radioimmunoassay method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30.5Centimeter

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(800)854-0530custserv@mpbio.com

Regulatory Flags#

DUNS number
137825928
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817830023211MP Biomedicals LLC07189105071891052023-08-03
00817830023228MP Biomedicals LLC07596303075963032023-08-03
00817830023235MP Biomedicals LLC07596307075963072023-08-03
00817830023006MP Biomedicals LLC06B25501706B2550172023-08-02
00817830023075MP Biomedicals LLC07140202071402022023-08-02
00817830023082MP Biomedicals LLC07140205071402052023-08-02
00817830023099MP Biomedicals LLC07553300075533002023-08-02
00817830023105MP Biomedicals LLC07553303075533032023-08-02
00817830023112MP Biomedicals LLC07553305075533052023-08-02
00817830023129MP Biomedicals LLC07553306075533062023-08-02
00817830023136MP Biomedicals LLC06B25502506B2550252023-08-02
00817830023143MP Biomedicals LLC07152101071521012023-08-02
00817830023150MP Biomedicals LLC07171102071711022023-08-02
00817830023167MP Biomedicals LLC07170102071701022023-08-02
00817830023174MP Biomedicals LLC07170105071701052023-08-02
00817830023181MP Biomedicals LLC07270102072701022023-08-02
00817830023198MP Biomedicals LLC07270105072701052023-08-02
00817830023204MP Biomedicals LLC07189102071891022023-08-02
00817830023013MP Biomedicals LLC07109202071092022023-08-01
00817830023020MP Biomedicals LLC07230102072301022023-08-01

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Primary DI, Brand, Company table
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00850054026484QMedix™Diagnostic Automation, Inc.CDX2024-01-31
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00840239045591Mycoplasma hominis IgG ELISADRG International IncCDX2023-08-25
00840239045683T-4 Total ELISADRG International IncCDX2023-08-25
06925912718512iFlash-T4Shenzhen YHLO Biotech Co., Ltd.CDX2022-10-26
07613336171660Elecsys T4Roche Diagnostics GmbHCDX2021-08-13
07613336171677Elecsys T4Roche Diagnostics GmbHCDX2021-08-13
00816870021218N-T4 AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CDX2019-02-11
00816870021225N-T4 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CDX2019-02-11
00816870021232N-T4 AccuBind ELISA Test System - 480 WellsMONOBIND, INC.CDX2019-02-11
00816870021249N-T4 AccuBind ELISA Test System - 960 WellsMONOBIND, INC.CDX2019-02-11
00816870021256N-T4 AccuBind ELISA Test System - 1920 WellsMONOBIND, INC.CDX2019-02-11
00816870021652T4 AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CDX2019-02-11
00816870021669T4 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CDX2019-02-11
00816870021676T4 AccuBind ELISA Test System - 480 WellsMONOBIND, INC.CDX2019-02-11
00816870021683T4 AccuBind ELISA Test System - 960 WellsMONOBIND, INC.CDX2019-02-11
00816870021690T4 SBS AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CDX2019-02-11
00816870021706T4 SBS AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CDX2019-02-11
00816870023090T4 AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CDX2019-02-11
00816870023106Monobind AccuLite T4 CLIA Kit - 192 WellsMONOBIND, INC.CDX2019-02-11
00816870023113T4 AccuLite CLIA Test System - 480 WellsMONOBIND, INC.CDX2019-02-11
00816870023120T4 AccuLite CLIA Test System - 960 WellsMONOBIND, INC.CDX2019-02-11
00816870023137T4 SBS AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CDX2019-02-11
00816870023144T4 SBS AccuLite CLIA Test System - 192 WellsMONOBIND, INC.CDX2019-02-11
00630414599984Atellica IM T4Siemens Healthcare Diagnostics Inc.CDX2018-02-06
00630414599991Atellica IM T4 DILSiemens Healthcare Diagnostics Inc.CDX2018-02-06
04015630939800Elecsys T4Roche Diagnostics GmbHCDX2017-04-21
00817830022467Total T4 MAb 125I RIA KitMP BIOMEDICALS, LLCCDX2016-10-20
00817830022481Total T4 MAb 125I RIA KitMP BIOMEDICALS, LLCCDX2016-10-20
00630414125121ADVIA Centaur® T4 DILSiemens Healthcare Diagnostics Inc.CDX2016-09-24