c-erbB-2/HER2

GUDID 00847627035387

BIOCARE MEDICAL LLC

C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody C-erbB2/Her2/neu oncoprotein IVD, antibody
Primary Device ID00847627035387
NIH Device Record Keyb22d1cb3-674c-423f-914b-da85201e64f0
Commercial Distribution StatusIn Commercial Distribution
Brand Namec-erbB-2/HER2
Version Model NumberAVA342G
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
GS100847627035387 [Primary]

FDA Product Code

MVUReagents, Specific, Analyte

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-12
Device Publish Date2023-12-04

On-Brand Devices [c-erbB-2/HER2]

00847627031129APA342H
00847627025326OPAA342T60
00847627002013APA342AA
00847627001481ACA342B
00847627001474ACA342A
00847627035387AVA342G

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