PRAME [EPR20330]

GUDID 00847627034984

BIOCARE MEDICAL LLC

Preferentially expressed antigen in melanoma (PRAME) IVD, antibody Preferentially expressed antigen in melanoma (PRAME) IVD, antibody Preferentially expressed antigen in melanoma (PRAME) IVD, antibody Preferentially expressed antigen in melanoma (PRAME) IVD, antibody Preferentially expressed antigen in melanoma (PRAME) IVD, antibody Preferentially expressed antigen in melanoma (PRAME) IVD, antibody Preferentially expressed antigen in melanoma (PRAME) IVD, antibody Preferentially expressed antigen in melanoma (PRAME) IVD, antibody Preferentially expressed antigen in melanoma (PRAME) IVD, antibody Preferentially expressed antigen in melanoma (PRAME) IVD, antibody Preferentially expressed antigen in melanoma (PRAME) IVD, antibody Preferentially expressed antigen in melanoma (PRAME) IVD, antibody Preferentially expressed antigen in melanoma (PRAME) IVD, antibody Preferentially expressed antigen in melanoma (PRAME) IVD, antibody Preferentially expressed antigen in melanoma (PRAME) IVD, antibody Preferentially expressed antigen in melanoma (PRAME) IVD, antibody Preferentially expressed antigen in melanoma (PRAME) IVD, antibody
Primary Device ID00847627034984
NIH Device Record Keye442ad1e-608e-4d1c-a0db-3fc19b7b3e1c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRAME [EPR20330]
Version Model NumberACI3252C
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
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
GS100847627034984 [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 Date2023-07-07
Device Publish Date2023-06-29

On-Brand Devices [PRAME [EPR20330]]

00847627030894API3252G20
00847627030689ACI3252B
00847627029041AVI3252G25
00847627029003API3252H
00847627027566ALI3252G7
00847627027559OPAI3252T60
00847627025067AVI3252G
00847627025050API3252AA
00847627025043ACI3252A
00847627034991ALI3252H
00847627034984ACI3252C

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