Identity
- Trade Name
- Ovulation test FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, reagent FDA UDI
- Model / Reference
- GM-700O FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09351337000081 FDA UDI
- FDA Product Code
- LCX FDA UDI
- GMDN Term
- Total human chorionic gonadotropin IVD, reagent 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: Total human chorionic gonadotropin IVD, reagent
Ovulation test by Generation Guard Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total human chorionic gonadotropin IVD, reagent.
- Tanner Scientific® — MERCEDES MEDICAL LLC · Class II
- LSL HEALTHCARE — Lsl Industries, Inc. · Class I
- LEADER — Cardinal Health 110, Inc. · Class II
- AIA-PACK HCG SAMPLE DILUTING SOLUTION — Tosoh Corp. · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
- Ovulation and Pregnancy test Kit — GENERATION GUARD PTY LTD · Class II
- Pregnancy test — GENERATION GUARD PTY LTD · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Generation Guard Pty Ltd
Sources (1)
- FDA UDI 821968e5-bd21-497a-ae72-7a7c41bf0068 32 fields · synced May 30, 2026