Identity
- Trade Name
- AQC FDA UDI
- Generic Name
- Sperm antibody IVD, control FDA UDI
- Device Name
- Antisperm Antibody Quality Control for semen analysis. Contains 8 vials of human sera, 4 positive and 4 negative for IgG antisperm antibodies. Each vial contains 500 µL. https://www.fertilitysolutions.com/product-category/antisperm-antibody-quality-control FDA UDI
- Model / Reference
- AQC109 FDA UDI
- Description
- Antisperm Antibody Quality Control for semen analysis. Contains 8 vials of human sera, 4 positive and 4 negative for IgG antisperm antibodies. Each vial contains 500 µL. https://www.fertilitysolutions.com/product-category/antisperm-antibody-quality-control FDA UDI
Identifiers
- Catalog Number
- AQC109 FDA UDI
- Primary DI / UDI-DI
- 00860010518175 FDA UDI
- FDA Product Code
- DGQ FDA UDI
- GMDN Term
- Sperm antibody IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.5700 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sperm antibody IVD, control
Aqc by Fertility Solutions, 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
- Fertility Solutions, Inc.
Sources (1)
- FDA UDI 725be751-b34a-4004-b6a9-91aa8268a522 37 fields · synced Jun 8, 2026