MCM2 + TOP2A

GUDID 00847627039279

BIOCARE MEDICAL LLC

Multiple solid tumour differentiation marker IVD, antibody
Primary Device ID00847627039279
NIH Device Record Key30309810-609d-485a-a23a-b33eda4fe6d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameMCM2 + TOP2A
Version Model NumberNPAI3181T40
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100847627039279 [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 Date2025-03-28
Device Publish Date2025-03-20

On-Brand Devices [MCM2 + TOP2A]

00847627004642API3181H
00847627004635API3181AA
00847627035462AVI3181G
00847627039590NPAI3181T80
00847627039279NPAI3181T40

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