Histoplasma Antigen for Fungal Immunodiffusion 100201

GUDID 00840733101021

Histoplasma capsulatum antigen reagents are standardized, purified preparations for the in vitro determination of precipitating antibodies to Histoplasma capsulatum (H. cap.). These reagents are optimized for use in the Ouchterlony double diffusion.

MERIDIAN BIOSCIENCE, INC.

Histoplasma capsulatum antigen IVD, reagent
Primary Device ID00840733101021
NIH Device Record Key133f14ef-4667-4fe6-b6fe-09f27914f883
Commercial Distribution StatusIn Commercial Distribution
Brand NameHistoplasma Antigen for Fungal Immunodiffusion
Version Model Number100201
Catalog Number100201
Company DUNS092815364
Company NameMERIDIAN BIOSCIENCE, INC.
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 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

Phone513-271-3700
Emailinfo@meridianbioscience.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840733101021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GMJAntigens, Histoplasma Capsulatum, All

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-06

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