ANA Homogeneous Control ANP-1040

GUDID B110ANP10400

Bion Enterprises, Ltd.

Multiple antinuclear antibody (ANA) screening IVD, control
Primary Device IDB110ANP10400
NIH Device Record Keyda953991-c5e0-4958-bc27-94558043d8e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameANA Homogeneous Control
Version Model NumberANP-1040
Catalog NumberANP-1040
Company DUNS024824641
Company NameBion Enterprises, Ltd.
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone847-544-5044
Emailbion@mblintl.com
Phone847-544-5044
Emailbion@mblintl.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB110ANP10400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-04
Device Publish Date2016-09-12

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