Anti-ER (Insite) AM368-10M

GUDID 00850646007082

BIOGENEX LABORATORIES

Estrogen (oestrogen)/progesterone receptor IVD, antibody
Primary Device ID00850646007082
NIH Device Record Keyf16250a2-e993-426b-8819-9744d24e742d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti-ER (Insite)
Version Model NumberAM368-10M
Catalog NumberAM368-10M
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 Volume10 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850646007082 [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 Date2016-09-23

On-Brand Devices [Anti-ER (Insite)]

00850646007143AM368-5MSG
00850646007112MU368-5UC
00850646007105AX368-50D
00850646007099AX368-YCD
00850646007082AM368-10M
00850646007075AM368-5M
00850646007068MU368-UC

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