Measles IgM Control MEM-6030

GUDID B110MEM60300

Bion Enterprises, Ltd.

Measles virus immunoglobulin M (IgM) antibody IVD, control
Primary Device IDB110MEM60300
NIH Device Record Key32ab9b9c-9cd2-4467-9930-6df7c74fece0
Commercial Distribution StatusIn Commercial Distribution
Brand NameMeasles IgM Control
Version Model NumberMEM-6030
Catalog NumberMEM-6030
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 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

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
HIBCCB110MEM60300 [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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