MOC-31

GUDID 00847627039170

BIOCARE MEDICAL LLC

Epithelial cell adhesion molecule (EpCAM) IVD, antibody
Primary Device ID00847627039170
NIH Device Record Key2a5ec651-4307-4138-8081-f33f5bb1eafc
Commercial Distribution StatusIn Commercial Distribution
Brand NameMOC-31
Version Model NumberNPAI403T40
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
GS100847627039170 [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 [MOC-31]

00847627025364OPAI403T60
00847627024879AVI403G
00847627011848PM403AA
00847627007384CM403C
00847627007377CM403A
00847627039170NPAI403T40

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