Chlamydia Antigen Substrate, 12 wells, For IFA Test System CH-4112

GUDID B110CH41120

Bion Enterprises, Ltd.

Multiple Chlamydia species total antibody IVD, reagent
Primary Device IDB110CH41120
NIH Device Record Keye3b4a928-f6b3-4f02-abcf-9ceb913d170c
Commercial Distribution StatusIn Commercial Distribution
Brand NameChlamydia Antigen Substrate, 12 wells, For IFA Test System
Version Model NumberCH-4112
Catalog NumberCH-4112
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
HIBCCB110CH41120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKIAntisera, Fluorescent, Chlamydia Spp.

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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