Measles IgM Test System, 120 Tests MEM-120

GUDID B110MEM1200

Bion Enterprises, Ltd.

Measles virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
Primary Device IDB110MEM1200
NIH Device Record Keyad5969a3-9064-4e05-9b51-f6c6d99df83a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMeasles IgM Test System, 120 Tests
Version Model NumberMEM-120
Catalog NumberMEM-120
Company DUNS024824641
Company NameBion Enterprises, Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
HIBCCB110MEM1200 [Primary]

FDA Product Code

GREAntiserum, Fluorescent, Rubeola

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-04
Device Publish Date2016-09-12

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