HLA-B [BC43]

GUDID 00847627032232

BIOCARE MEDICAL LLC

HLA class I antigen non-tissue typing IVD, antibody HLA class I antigen non-tissue typing IVD, antibody HLA class I antigen non-tissue typing IVD, antibody HLA class I antigen non-tissue typing IVD, antibody HLA class I antigen non-tissue typing IVD, antibody HLA class I antigen non-tissue typing IVD, antibody HLA class I antigen non-tissue typing IVD, antibody HLA class I antigen non-tissue typing IVD, antibody HLA class I antigen non-tissue typing IVD, antibody HLA class I antigen non-tissue typing IVD, antibody HLA class I antigen non-tissue typing IVD, antibody HLA class I antigen non-tissue typing IVD, antibody HLA class I antigen non-tissue typing IVD, antibody HLA class I antigen non-tissue typing IVD, antibody HLA class I antigen non-tissue typing IVD, antibody HLA class I antigen non-tissue typing IVD, antibody HLA class I antigen non-tissue typing IVD, antibody
Primary Device ID00847627032232
NIH Device Record Keyb85e72b3-9bb5-4116-82ac-1d612b877428
Commercial Distribution StatusIn Commercial Distribution
Brand NameHLA-B [BC43]
Version Model NumberALI3289G7
Company DUNS806617825
Company NameBIOCARE MEDICAL LLC
Device Count1
DM Exempttrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100847627032232 [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 Date2023-09-13
Device Publish Date2023-09-05

On-Brand Devices [HLA-B [BC43]]

00847627032249AVI3289G
00847627032232ALI3289G7
00847627032225OPAI3289T60
00847627032218API3289AA
00847627032201ACI3289C
00847627032195ACI3289A

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