Anti-PR (Insite) AX328-50D

GUDID 00850646007044

BIOGENEX LABORATORIES

Progesterone receptor IVD, antibody
Primary Device ID00850646007044
NIH Device Record Keye7435d0b-6e28-4329-83d9-3f1d6d5e58b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti-PR (Insite)
Version Model NumberAX328-50D
Catalog NumberAX328-50D
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 Volume5 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850646007044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MXZImmunohistochemistry Assay,Antibody,Progesterone 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-PR (Insite)]

00850646007129AM328-5MSG
00850646007051MU328-5UC
00850646007044AX328-50D
00850646007037AX328-YCD
00850646007020AM328-10M
00850646007013AM328-5M
00850646007006MU328-UC

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