BioCheck T4 EIA Test Kit BC-1007

GUDID 00850392007077

The BioCheck T4 EIA Test Kit is intended for the quantitative determination of total thyroxine (T4) concentration in human serum.

BIOCHECK, INC.

Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00850392007077
NIH Device Record Keya26e80a7-2ec2-413d-9e12-d9a7c0b661c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioCheck T4 EIA Test Kit
Version Model NumberBC-1007
Catalog NumberBC-1007
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
GS100850392007077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

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.

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