Identity
- Trade Name
- ST AIA-PACK βHCG FDA UDI
- Generic Name
- Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- N/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14560189210063 FDA UDI
- FDA Product Code
- JHI FDA UDI
- GMDN Term
- Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1155 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, enzyme immunoassay (EIA)
St Aia-Pack Βhcg by Tosoh Corp. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Tosoh Corp.
Sources (1)
- FDA UDI 88a92b2f-6545-4e0c-a051-f378d919f857 34 fields · synced May 31, 2026