Coccidioides "TP" Antigen for Fungal Immunodiffusion - Coccidioides immitis antigen reagents are - MERIDIAN BIOSCIENCE, INC.

Duns Number:092815364

Device Description: Coccidioides immitis antigen reagents are standardized, purified preparations for the in v 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.

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More Product Details

Catalog Number

103001

Brand Name

Coccidioides "TP" Antigen for Fungal Immunodiffusion

Version/Model Number

103001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K792682

Product Code Details

Product Code

GMI

Product Code Name

Antigen, Cf And/Or Id, Coccidioides Immitis

Device Record Status

Public Device Record Key

9a9ecf08-f2b8-4698-9945-f4b7587d231f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MERIDIAN BIOSCIENCE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 149
2 A medical device with a moderate to high risk that requires special controls. 46
3 A medical device with high risk that requires premarket approval 1