HER2/neu [IHC042]

GUDID 00847627030320

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
Primary Device ID00847627030320
NIH Device Record Keyf0d29ce8-7e6b-47c0-b3ba-d5739e9873bf
Commercial Distribution StatusIn Commercial Distribution
Brand NameHER2/neu [IHC042]
Version Model NumberACA3274B
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100847627030320 [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 Date2023-06-22
Device Publish Date2023-06-14

On-Brand Devices [HER2/neu [IHC042]]

00847627030368OPAA3274T60
00847627030351AVA3274G
00847627030344ALA3274G7
00847627030337APA3274AA
00847627030320ACA3274B
00847627030313ACA3274A

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