Coccidioides "TP" Antigen for Fungal Immunodiffusion 103001

GUDID 00840733101076

Coccidioides immitis antigen reagents are standardized, purified preparations for the in vitro determination of precipitating antibodies to Coccidioides immitis (C. imm.). Reagents are available for detection of either “TP” (early) or “F” (late) antibodies. These reagents are optimized for use in the Ouchterlony double diffusion.

MERIDIAN BIOSCIENCE, INC.

Coccidioides immitis total antibody IVD, kit, precipitation/immunodiffusion
Primary Device ID00840733101076
NIH Device Record Key9a9ecf08-f2b8-4698-9945-f4b7587d231f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoccidioides "TP" Antigen for Fungal Immunodiffusion
Version Model Number103001
Catalog Number103001
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
GS100840733101076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GMIAntigen, Cf And/Or Id, Coccidioides Immitis

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 Date2016-09-23

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