Mycoplasma pneumoniae Antigen Substrate, 12 wells, For IFA Test System MP-1212

GUDID B110MP12120

Bion Enterprises, Ltd.

Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, reagent
Primary Device IDB110MP12120
NIH Device Record Key31591476-e2b7-45c6-9961-e7401d6a50c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameMycoplasma pneumoniae Antigen Substrate, 12 wells, For IFA Test System
Version Model NumberMP-1212
Catalog NumberMP-1212
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 Usetrue
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 0 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB110MP12120 [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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