Anti-Histoplasma Control Serum (Goat) for Immunodiffusion 100601

GUDID 00840733101052

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, control
Primary Device ID00840733101052
NIH Device Record Keya924d9b9-b2e1-4473-9669-70f6bf98e94e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti-Histoplasma Control Serum (Goat) for Immunodiffusion
Version Model Number100601
Catalog Number100601
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
GS100840733101052 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GMKAntiserum, Positive Control, Histoplasma Capsulatum

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 Date2016-09-22

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