Measles Negative Control MEN-6010

GUDID B110MEN60100

Bion Enterprises, Ltd.

Measles virus immunoglobulin G (IgG) antibody IVD, control Measles virus immunoglobulin G (IgG) antibody IVD, control
Primary Device IDB110MEN60100
NIH Device Record Keya9eb9a77-fa08-4be8-90e9-44dec474d213
Commercial Distribution StatusIn Commercial Distribution
Brand NameMeasles Negative Control
Version Model NumberMEN-6010
Catalog NumberMEN-6010
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
HIBCCB110MEN60100 [Primary]

FDA Product Code

GREAntiserum, Fluorescent, Rubeola

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

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.