Respiratory Syncytial Virus Antigen Substrate, 12 wells, For IFA Test System RS-9012

GUDID B110RS90120

Bion Enterprises, Ltd.

Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, reagent
Primary Device IDB110RS90120
NIH Device Record Key94a6e2c4-d88f-42b5-b9ce-6064955db7d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameRespiratory Syncytial Virus Antigen Substrate, 12 wells, For IFA Test System
Version Model NumberRS-9012
Catalog NumberRS-9012
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 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
HIBCCB110RS90120 [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

Devices Manufactured by Bion Enterprises, Ltd.

B110BBM61300 - Borrelia IgM Control2020-04-09
B110RGM7612D0 - BP 180 ELISA TEST2020-04-09
B110ACA10430 - ANA ACA Control2020-03-04
B110AD31120 - Adenovirus Antigen Substrate, 12 wells, For IFA Test System2020-03-04
B110ADG31200 - Adenovirus IgG Control2020-03-04
B110ADN31100 - Adenovirus Negative Control2020-03-04
B110AN10060 - Antinuclear Antibody HEp-2 Antigen Substrate 6 wells, For IFA Test System2020-03-04
B110AN10120 - Antinuclear Antibody HEp-2 Antigen Substrate, 12 wells, For IFA Test System2020-03-04

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.