FDA.reportPublic FDA data

TSH Coated Tube 125I RIA Kit

Primary DI
00817830022375
Brand
TSH Coated Tube 125I RIA Kit
Company
MP BIOMEDICALS, LLC
Model
07294105
Catalog number
07294105
Device description
Radioimmunoassay for the quantitative determination of Thyroid stimulating hormone (TSH) 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
JLWRADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K865071000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K865071000THYROID STIMULATING HORMONE (TSH IRMA) RIA KITImmuchem Corp.1987-03-13JLW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817830022375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817830022375008178300223758178300223750817830022375

GMDN Terms#

Term, Definition table
TermDefinition
Thyroid stimulating hormone (TSH) IVD, kit, radioimmunoassayA 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 radioimmunoassay method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25.5Centimeter

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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00630414624518Atellica IM TSH3-Ultra IISiemens Healthcare Diagnostics Inc.JLW2024-05-22
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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
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04048474041118Thyrotropin (TSH) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungJLW2023-08-31
04048474017823Thyroid Stimulating Hormone (TSH) ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLW2023-08-26
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07613336193693Elecsys TSHRoche Diagnostics GmbHJLW2022-11-18
06947145500016MAGLUMI 2000 TSHShenzhen New Industries Biomedical Engineering Co., Ltd.JLW2022-08-02
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00725609000618SPOTCHECKASTORIA-PACIFIC, INC.JLW2020-12-17
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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
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