Identity
- Trade Name
- OvuSign® LH card FDA UDI
- Generic Name
- Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- OvuSign LH EUDAMEDOvuSign® LH card; 35 Test Kit; CE FDA UDI
- Model / Reference
- OSH-143-35 EUDAMEDOSH-143-35-01 FDA UDI
- Description
- OvuSign® LH card; 35 Test Kit; CE FDA UDI
Identifiers
- Catalog Number
- OSH-143-35-01 FDA UDI
- Primary DI / UDI-DI
- 10743816000778 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10743816000778 EUDAMED
- FDA Product Code
- CEP FDA UDI
- EMDN Code
- W0102160304 LH - RT & POC EUDAMED
- GMDN Term
- Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1485 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: Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
OvuSign® LH card by Princeton Biomeditech Corp. — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical.
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- FERTICARE — Weihai Kangzhou Biotechnology Engineering Co., Ltd · Class I
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- Natural Cycles — Natural Cycles Nordic AB · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Princeton Biomeditech Corp.
Sources (2)
- FDA UDI 443c4c89-0cf3-4118-9b19-607263734835 35 fields · synced Jul 17, 2026
- EUDAMED 9dfb85ba-9c87-469e-9be3-ff7f9da3faaf 61 fields · synced Jul 17, 2026