CMV IgG Test System, 120 Tests CMG-120

GUDID B110CMG1200

Bion Enterprises, Ltd.

Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Primary Device IDB110CMG1200
NIH Device Record Keyb7b8c7c6-8f70-488a-bd51-c581d85a0056
Commercial Distribution StatusIn Commercial Distribution
Brand NameCMV IgG Test System, 120 Tests
Version Model NumberCMG-120
Catalog NumberCMG-120
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 Kittrue
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
HIBCCB110CMG1200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GQHAntigen, Cf (Including Cf Control), Cytomegalovirus

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.