GITR [CAL8]

GUDID 00847627014009

BIOCARE MEDICAL LLC

Tumour necrosis factor receptor superfamily IVD, antibody Tumour necrosis factor receptor superfamily IVD, antibody Tumour necrosis factor receptor superfamily IVD, antibody Tumour necrosis factor receptor superfamily IVD, antibody Tumour necrosis factor receptor superfamily IVD, antibody Tumour necrosis factor receptor superfamily IVD, antibody Tumour necrosis factor receptor superfamily IVD, antibody Tumour necrosis factor receptor superfamily IVD, antibody Tumour necrosis factor receptor superfamily IVD, antibody Tumour necrosis factor receptor superfamily IVD, antibody Tumour necrosis factor receptor superfamily IVD, antibody Tumour necrosis factor receptor superfamily IVD, antibody Tumour necrosis factor receptor superfamily IVD, antibody Tumour necrosis factor receptor superfamily IVD, antibody
Primary Device ID00847627014009
NIH Device Record Key3b91b314-9002-48a6-8b75-baa22980425f
Commercial Distribution StatusIn Commercial Distribution
Brand NameGITR [CAL8]
Version Model NumberAPI3221AA
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 Perscriptionfalse
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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100847627014009 [Primary]

FDA Product Code

NJTImmunohistochemistry Reagents And Kits

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-04-26
Device Publish Date2022-12-13

On-Brand Devices [GITR [CAL8]]

00847627014009API3221AA
00847627013965ACI3221B
00847627013958ACI3221A

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.