Anti-ER MU368-100

GUDID 00850646007150

BIOGENEX LABORATORIES

Estrogen (oestrogen)/progesterone receptor IVD, antibody
Primary Device ID00850646007150
NIH Device Record Key7e8cdb6d-516f-4563-837f-290eee0e7f46
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti-ER
Version Model NumberMU368-100
Catalog NumberMU368-100
Company DUNS042697045
Company NameBIOGENEX LABORATORIES
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (800) 421-4149
Emailsupport@biogenex.com

Device Dimensions

Total Volume0.1 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°c

Device Identifiers

Device Issuing AgencyDevice ID
GS100850646007150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MYAImmunohistochemistry Antibody Assay, Estrogen Receptor

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-14

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