ANA (HEp-2) Test System, 120 Tests ANK-120

GUDID B110ANK1200

Bion Enterprises, Ltd.

Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay
Primary Device IDB110ANK1200
NIH Device Record Key583ae03d-aeef-4ba1-bacb-7f0ce90504dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameANA (HEp-2) Test System, 120 Tests
Version Model NumberANK-120
Catalog NumberANK-120
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 Kittrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB110ANK1200 [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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