RSV Negative Control RSN-9010

GUDID B110RSN90100

Bion Enterprises, Ltd.

Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, control
Primary Device IDB110RSN90100
NIH Device Record Key0ac9a5fa-2aac-4300-9d9f-8c29c19582aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameRSV Negative Control
Version Model NumberRSN-9010
Catalog NumberRSN-9010
Company DUNS024824641
Company NameBion Enterprises, Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
HIBCCB110RSN90100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKTRespiratory Syncytial Virus, Antigen, Antibody, Ifa

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-04
Device Publish Date2016-09-12

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