Identity
- Trade Name
- One + Step FDA UDI
- Generic Name
- Human chorionic gonadotropin alpha-subunit IVD, calibrator FDA UDI
- Model / Reference
- HCG-U23 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055718942345 FDA UDI
- 510(k) Number
- K123050 FDA UDI
- FDA Product Code
- LCX FDA UDI
- GMDN Term
- Human chorionic gonadotropin alpha-subunit IVD, calibrator 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Human chorionic gonadotropin alpha-subunit IVD, calibrator
One + Step by Nantong Egens Biology Technic Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Nantong Egens Biology Technic Co., Ltd.
Sources (1)
- FDA UDI 40839d93-2a71-4a25-aab6-285011e33cf6 33 fields · synced May 30, 2026