Parainfluenza 1, 2, & 3 Negative Control PN-8510

GUDID B110PN85100

Bion Enterprises, Ltd.

Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, control Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, control
Primary Device IDB110PN85100
NIH Device Record Key9d3aa8d6-fede-4bd4-94cd-7a26d1221e96
Commercial Distribution Discontinuation2017-01-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameParainfluenza 1, 2, & 3 Negative Control
Version Model NumberPN-8510
Catalog NumberPN-8510
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
HIBCCB110PN85100 [Primary]

FDA Product Code

GQQAntisera, Hai, Parainfluenza Virus 1-4

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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