Identity
- Trade Name
- BioSign® RC hCG S/U card FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- BioSign RC hCG serum/urine card EUDAMEDBioSign® RC hCG S/U card; 35 Test kit; CE FDA UDI
- Model / Reference
- BSP-122-35 EUDAMEDBSP-122-35-00 FDA UDI
- Description
- BioSign® RC hCG S/U card; 35 Test kit; CE FDA UDI
Identifiers
- Catalog Number
- BSP-122-35-00 FDA UDI
- Primary DI / UDI-DI
- 10743816000709 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10743816000709 EUDAMED
- FDA Product Code
- JHI FDA UDI
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
- GMDN Term
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1155 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
Yes
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
BioSign® RC hCG S/U card by Princeton Biomeditech Corp. — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Princeton Biomeditech Corp.
Sources (2)
- FDA UDI b290426c-4065-409d-937f-ac3ba456535a 36 fields · synced Jul 21, 2026
- EUDAMED a963eda1-ec5a-463a-ba7d-e5e9dfcf98cd 61 fields · synced Jul 21, 2026