BioCheck U-TSH EIA Test Kit BC-1003

GUDID 00850392007039

The BioCheck U-TSH EIA Test Kit is intended for the quantitative determination of thyroid stimulating hormone (TSH) concentration in human serum.

BIOCHECK, INC.

Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00850392007039
NIH Device Record Key0cf10fd3-a00f-4bf6-a22f-179ab9ac5eca
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioCheck U-TSH EIA Test Kit
Version Model NumberBC-1003
Catalog NumberBC-1003
Company DUNS171857493
Company NameBIOCHECK, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(650)573-1968
Emailinfo@biocheckinc.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850392007039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JLWRadioimmunoassay, Thyroid-Stimulating Hormone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-16
Device Publish Date2019-10-08

Devices Manufactured by BIOCHECK, INC.

00850392007015 - BioCheck TSH EIA Test Kit2019-10-16 The BioCheck TSH EIA Test Kit is intended for the quantitative determination of thyroid stimulating hormone (TSH) concentration
00850392007039 - BioCheck U-TSH EIA Test Kit2019-10-16The BioCheck U-TSH EIA Test Kit is intended for the quantitative determination of thyroid stimulating hormone (TSH) concentration in human serum.
00850392007039 - BioCheck U-TSH EIA Test Kit2019-10-16 The BioCheck U-TSH EIA Test Kit is intended for the quantitative determination of thyroid stimulating hormone (TSH) concentratio
00850392007053 - BioCheck T3 EIA Test Kit2019-10-16 The BioCheck T3 EIA Test Kit is intended for the quantitative determination of triiodothyronine (T3) concentration in human seru
00850392007077 - BioCheck T4 EIA Test Kit2019-10-16 The BioCheck T4 EIA Test Kit is intended for the quantitative determination of total thyroxine (T4) concentration in human serum
00850392007176 - BioCheck Myoglobin EIA Test Kit2019-10-16 The BioCheck Myoglobin EIA Test Kit is intended for the quantitative determination of myoglobin in human serum.
00850392007190 - BioCheck High Sensitive CRP EIA Test Kit2019-10-16 BioCheck HS-CRP ELISA Kit is intended for the quantitative determination of C-Reactive Protein (CRP) in human serum.
00850392007251 - BioCheck Human Ferritin EIA Test Kit2019-10-16 The BioCheck Human Ferritin EIA Test Kit is intended for the quantitative determination of ferritin in human serum.
00850392007275 - BioCheck hCG EIA Test Kit2019-10-16 The BioCheck hCG EIA Test Kit is intended for the quantitative determination of human chorionic gonadotropin (hCG) concentration

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