ARC – Antigen Retrieval Chamber

GUDID 00847627030870

BIOCARE MEDICAL LLC

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Primary Device ID00847627030870
NIH Device Record Keya27394e5-36d0-4b81-88a7-05e20c25be5a
Commercial Distribution StatusIn Commercial Distribution
Brand NameARC – Antigen Retrieval Chamber
Version Model NumberDCARC0001
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100847627030870 [Primary]

FDA Product Code

LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-13
Device Publish Date2023-11-03

On-Brand Devices [ARC – Antigen Retrieval Chamber]

00847627030887DCARC0001-R
00847627030870DCARC0001

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