PD-L1

GUDID 00847627034083

BIOCARE MEDICAL LLC

Programmed death-ligand 1 (PD-L1) IVD, antibody Programmed death-ligand 1 (PD-L1) IVD, antibody Programmed death-ligand 1 (PD-L1) IVD, antibody Programmed death-ligand 1 (PD-L1) IVD, antibody Programmed death-ligand 1 (PD-L1) IVD, antibody Programmed death-ligand 1 (PD-L1) IVD, antibody Programmed death-ligand 1 (PD-L1) IVD, antibody Programmed death-ligand 1 (PD-L1) IVD, antibody Programmed death-ligand 1 (PD-L1) IVD, antibody Programmed death-ligand 1 (PD-L1) IVD, antibody Programmed death-ligand 1 (PD-L1) IVD, antibody Programmed death-ligand 1 (PD-L1) IVD, antibody Programmed death-ligand 1 (PD-L1) IVD, antibody Programmed death-ligand 1 (PD-L1) IVD, antibody Programmed death-ligand 1 (PD-L1) IVD, antibody Programmed death-ligand 1 (PD-L1) IVD, antibody Programmed death-ligand 1 (PD-L1) IVD, antibody Programmed death-ligand 1 (PD-L1) IVD, antibody
Primary Device ID00847627034083
NIH Device Record Key2e47a021-237d-42cc-b661-4d84ec1f55e8
Commercial Distribution StatusIn Commercial Distribution
Brand NamePD-L1
Version Model NumberALI3171G7
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
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
GS100847627034083 [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 Date2023-03-09
Device Publish Date2023-03-01

On-Brand Devices [PD-L1]

00847627029027AVI3171G
00847627025289OPAI3171T60
00847627004567API3171AA
00847627003430ACI3171C
00847627003423ACI3171A
00847627034083ALI3171G7

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