Identity
- Trade Name
- Histoplasma Antigen for Fungal Immunodiffusion FDA UDI
- Generic Name
- Histoplasma capsulatum antigen IVD, reagent FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 100201 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 100201 FDA UDI
- Primary DI / UDI-DI
- 00840733101021 FDA UDI
- 510(k) Number
- K792701 FDA UDI
- FDA Product Code
- GMJ FDA UDI
- GMDN Term
- Histoplasma capsulatum antigen IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Histoplasma capsulatum antigen IVD, reagent
Histoplasma Antigen for Fungal Immunodiffusion by Meridian Bioscience, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Meridian Bioscience, Inc.
Sources (1)
- FDA UDI 133f14ef-4667-4fe6-b6fe-09f27914f883 37 fields · synced May 30, 2026