Identity
- Trade Name
- AFAC One Step HCG and Ovulation Urine test Kit FDA UDI
- Generic Name
- Natural conception assistance kit FDA UDI
- Device Name
- The convenience kit is consisiting of 50 ovulation test 3mm strips and 20 pregnancy test 3mm strips . FDA UDI
- Model / Reference
- 82238 FDA UDI
- Description
- The convenience kit is consisiting of 50 ovulation test 3mm strips and 20 pregnancy test 3mm strips . FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06938444982238 FDA UDI
- FDA Product Code
- OIE FDA UDI
- GMDN Term
- Natural conception assistance kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
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
AFAC One Step HCG and Ovulation Urine test Kit by Equinox Biotech Co., Ltd. — 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
- Equinox Biotech Co., Ltd.
Sources (1)
- FDA UDI ca7e5fe2-c1dd-4dbb-82d4-e1706fe0a98c 35 fields · synced May 30, 2026