MSH2

GUDID 00847627037558

BIOCARE MEDICAL LLC

MSH2 antigen IVD, antibody
Primary Device ID00847627037558
NIH Device Record Key600a990d-1707-4129-93fa-0c7fc0849494
Commercial Distribution StatusIn Commercial Distribution
Brand NameMSH2
Version Model NumberNPAI219T40
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 HumidityBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment HumidityBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment HumidityBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment HumidityBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment HumidityBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment HumidityBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment HumidityBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100847627037558 [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 Date2025-06-30
Device Publish Date2025-06-20

On-Brand Devices [MSH2]

00847627031815OPAI219T60
00847627026958ALI219G7
00847627014108PM219H
00847627011367PM219AA
00847627006851CM219CK
00847627006844CM219BK
00847627006837CM219AK
00847627004918AVI219G
00847627037565NPAI219T80
00847627037558NPAI219T40

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.