Identity
- Trade Name
- IMMY FDA UDI
- Generic Name
- Histoplasma capsulatum antigen IVD, reagent FDA UDI
- Device Name
- 100 ng/mL Histoplasma Galactomannan FDA UDI
- Model / Reference
- HGM000 FDA UDI
- Description
- 100 ng/mL Histoplasma Galactomannan FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816387020421 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Histoplasma capsulatum antigen IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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
Immy by Immuno-Mycologics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Histoplasma capsulatum antigen IVD, reagent.
- Histoplasma Antigen for Fungal Immunodiffusion — MERIDIAN BIOSCIENCE, INC. · Class II
- IMMY — Immuno-Mycologics, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Immuno-Mycologics, Inc.
Sources (1)
- FDA UDI 2a102a4f-d850-4715-9dd0-629f97936f2d 34 fields · synced Jun 6, 2026