FDA.reportPublic FDA data

BioCheck U-TSH EIA Test Kit

Primary DI
00850392007039
Brand
BioCheck U-TSH EIA Test Kit
Company
BIOCHECK, INC.
Model
BC-1003
Catalog number
BC-1003
Device description
The BioCheck U-TSH EIA Test Kit is intended for the quantitative determination of thyroid stimulating hormone (TSH) concentration in human serum.
Published
2019-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
K990993000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990993000BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003Biocheck, Inc.1999-06-22JLW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850392007039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850392007039008503920070398503920070390850392007039

GMDN Terms#

Term, Definition table
TermDefinition
Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA)A 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 an enzyme immunoassay (EIA) method.

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
(650)573-1968info@biocheckinc.com

Regulatory Flags#

DUNS number
171857493
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850392007015BioCheck TSH EIA Test KitBC-1001BC-10012019-10-08
00850392007053BioCheck T3 EIA Test KitBC-1005BC-10052019-10-08
00850392007077BioCheck T4 EIA Test KitBC-1007BC-10072019-10-08
00850392007176BioCheck Myoglobin EIA Test KitBC-1117BC-11172019-10-08
00850392007190BioCheck High Sensitive CRP EIA Test KitBC-1119BC-11192019-10-08
00850392007251BioCheck Human Ferritin EIA Test KitBC-1025BC-10252019-10-08
00850392007275BioCheck hCG EIA Test KitBC-1027BC-10272019-10-08
00850392007350BioCheck IgE EIA Test KitBC-1035BC-10352019-10-08
00850392007619BioCheck Beta-2 Microglobulin EIA Test KitBC-1061BC-10612019-10-08
00850392007152BioCheck Testosterone EIA Test KitBC-1115BC-11152019-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
06947145500023MAGLUMI 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
00840239014832Neonatal TSH ELISADRG International IncJLW2019-06-10
00840239041111Thyrotropin (TSH) ELISADRG International IncJLW2019-06-10
00840239052667T3-Uptake ELISADRG International IncJLW2019-06-06