Identity
- Trade Name
- IMMY FDA UDI
- Generic Name
- Aspergillus fumigatus total antibody IVD, kit, complement fixation test (CFT) FDA UDI
- Device Name
- Aspergillus CF Antigen Dilute FDA UDI
- Model / Reference
- A10150 FDA UDI
- Description
- Aspergillus CF Antigen Dilute FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816387020001 FDA UDI
- 510(k) Number
- K791387 FDA UDI
- FDA Product Code
- JWT FDA UDI
- GMDN Term
- Aspergillus fumigatus total antibody IVD, kit, complement fixation test (CFT) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3040 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
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: Aspergillus fumigatus total antibody IVD, kit, complement fixation test (CFT)
Immy by Immuno-Mycologics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 a849c737-0e94-41b6-b2e7-51403adedb48 35 fields · synced Jun 1, 2026