Tumor Associated Glycoprotein [B72.3]

GUDID 00847627041715

BIOCARE MEDICAL LLC

Tumour-associated glycoprotein-72 (TAG72) IVD, antibody
Primary Device ID00847627041715
NIH Device Record Keyb0e3344c-602a-4698-9344-14d87a71f371
Commercial Distribution StatusIn Commercial Distribution
Brand NameTumor Associated Glycoprotein [B72.3]
Version Model NumberNPAI002T40
Company DUNS806617825
Company NameBIOCARE MEDICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100847627041715 [Primary]

FDA Product Code

NJTImmunohistochemistry Reagents And Kits

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-26
Device Publish Date2025-08-18

Devices Manufactured by BIOCARE MEDICAL LLC

00847627041630 - PRAME [EPR20330]2025-08-26
00847627041692 - Hepatocyte Specific Antigen (HSA)2025-08-26
00847627041715 - Tumor Associated Glycoprotein [B72.3]2025-08-26
00847627041715 - Tumor Associated Glycoprotein [B72.3]2025-08-26
00847627041180 - INSM1 [BLR272L] 2025-08-18
00847627041463 - CD82025-08-18
00847627038913 - HMW CK + p63 (Basal Cell Cocktail) 2025-08-04
00847627039927 - E-cadherin2025-08-04
00847627039965 - CK5/14 + p63 + P504S2025-08-04

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.