Mycoplasma pneumoniae IgG Control MPG-1220

GUDID B110MPG12200

Bion Enterprises, Ltd.

Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, control Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, control
Primary Device IDB110MPG12200
NIH Device Record Key4c31bc78-c5b5-48d6-9527-b055ebbe8fcd
Commercial Distribution StatusIn Commercial Distribution
Brand NameMycoplasma pneumoniae IgG Control
Version Model NumberMPG-1220
Catalog NumberMPG-1220
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
HIBCCB110MPG12200 [Primary]

FDA Product Code

LQGDna-Reagents, Mycoplasma Spp.

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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