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Anti-Histoplasma Control Serum (Goat) for Immunodiffusion
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Anti-Histoplasma Control Serum (Goat) for Immunodiffusion FDA UDI
- Generic Name
- Histoplasma capsulatum antigen IVD, control 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
- 100601 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
- 100601 FDA UDI
- Primary DI / UDI-DI
- 00840733101052 FDA UDI
- 510(k) Number
- K792679 FDA UDI
- FDA Product Code
- GMK FDA UDI
- GMDN Term
- Histoplasma capsulatum antigen IVD, control 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, control
Anti-Histoplasma Control Serum (Goat) for 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 a924d9b9-b2e1-4473-9669-70f6bf98e94e 37 fields · synced May 30, 2026