p40 (M) [BC28]

GUDID 00847627037145

BIOCARE MEDICAL LLC

p40 protein IVD, antibody
Primary Device ID00847627037145
NIH Device Record Key6bbbac1f-b157-41a7-a5f5-b48ac4c8846e
Commercial Distribution StatusIn Commercial Distribution
Brand Namep40 (M) [BC28]
Version Model NumberNPAI3066T40
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100847627037145 [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 [p40 (M) [BC28]]

00847627037152NPAI3066T80
00847627037145NPAI3066T40

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