FDA.reportPublic FDA data

MAGLUMI 2000 TSH

Primary DI
06947145500023
Brand
MAGLUMI 2000 TSH
Company
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Model
130603013M
Catalog number
130603013M
Published
2022-08-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K162698000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162698000MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerShenzhen New Industries Biomedical Engineering Co., Ltd.2017-07-14JLW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06947145500023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06947145500023069471455000236947145500023

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

Regulatory Flags#

DUNS number
421745241
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06947145541781MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer0101010035010101010035012026-05-15
06947145547479MAGLUMI 25-OH Vitamin D130761601M130761601M2026-05-15
06947145547486MAGLUMI 25-OH Vitamin D130661601M130661601M2026-05-15
06947145547554MAGLUMI 25-OH Vitamin D130261601M130261601M2026-05-15
06947145578039MAGLUMI 2000 HCG/beta-HCG130602022M130602022M2024-05-11
06947145578046MAGLUMI 2000 HCG/beta-HCG130202022M130202022M2024-05-11
06947145578053MAGLUMI 2000 25-OH Vitamin D130211007M130211007M2023-05-17
06947145578060MAGLUMI 2000 25-OH Vitamin D130611007M130611007M2023-05-17
06947145582746Maglumi 2000 Immunoassay Analyzer23020006230200062022-12-31
06947145500016MAGLUMI 2000 TSH130203013M130203013M2022-08-02
06947145577971MAGLUMI 2000 FT4130603016M130603016M2022-08-02
06947145577988MAGLUMI 2000 FT4130203016M130203016M2022-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850049545044AccuDiag™Diagnostic Automation, Inc.JLW2024-11-14
00630414624488ADVIA Centaur TSH3-Ultra IISiemens Healthcare Diagnostics Inc.JLW2024-05-22
00630414624501ADVIA Centaur TSH3-Ultra IISiemens Healthcare Diagnostics Inc.JLW2024-05-22
00630414624518Atellica IM TSH3-Ultra IISiemens Healthcare Diagnostics Inc.JLW2024-05-22
00630414624525Atellica IM TSH3-Ultra IISiemens Healthcare Diagnostics Inc.JLW2024-05-22
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
04048474052664Total Triiodothyronine (tT3) ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLW2023-09-01
04048474052831Thyrotropin (TSH) ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLW2023-09-01
04048474041118Thyrotropin (TSH) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungJLW2023-08-31
04048474017823Thyroid Stimulating Hormone (TSH) ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLW2023-08-26
04048474017908TSH (ultrasensitive) ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLW2023-08-26
00840239052834Thyrotropin (TSH) ELISADRG International IncJLW2023-08-25
15099590744373Access TSH (3rd IS)Beckman Coulter, Inc.JLW2022-12-31
07613336193693Elecsys TSHRoche Diagnostics GmbHJLW2022-11-18
06947145500016MAGLUMI 2000 TSHShenzhen New Industries Biomedical Engineering Co., Ltd.JLW2022-08-02
00725609000618SPOTCHECKASTORIA-PACIFIC, INC.JLW2020-12-17
00630414293875Atellica IM TSH3-ULSiemens Healthcare Diagnostics Inc.JLW2020-12-12
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
00850392007015BioCheck TSH EIA Test KitBIOCHECK, INC.JLW2019-10-08
00850392007039BioCheck U-TSH EIA Test KitBIOCHECK, INC.JLW2019-10-08
00840239014832Neonatal TSH ELISADRG International IncJLW2019-06-10
00840239041111Thyrotropin (TSH) ELISADRG International IncJLW2019-06-10
00840239052667T3-Uptake ELISADRG International IncJLW2019-06-06