Identity
- Trade Name
- Ovulation Test FDA UDI
- Generic Name
- Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing FDA UDI
- Device Name
- Rapid chromatographic immunoassays for the qualitative detection of LH in urine, as an aid in detection of ovulation. This test is intended for over-the-counter use. FDA UDI
- Model / Reference
- LHUS FDA UDI
- Description
- Rapid chromatographic immunoassays for the qualitative detection of LH in urine, as an aid in detection of ovulation. This test is intended for over-the-counter use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860008449016 FDA UDI
- GMDN Term
- Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing
Ovulation Test by The Bird And Be Co Inc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing.
- Amazewell — Guangzhou Decheng Biotechnology Co., LTD · Class I
- Pregmate Ovulation Test Strips (25 Count) — PREGMATE LLC · Class I
- Amazewell — Guangzhou Decheng Biotechnology Co., LTD · Class I
- kozekoze — Guangzhou Decheng Biotechnology Co., LTD · Class I
- Wondfo — WONDFO USA CO., LTD. · Class I
- Pregmate 50 Ovulation and 20 Pregnancy Test Strips — PREGMATE LLC · Class I
- Pregmate Ovulation Test Strips (50 Count) — PREGMATE LLC · Class I
- Macro & Micro-Test LH Test — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. · Class I
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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- The Bird And Be Co Inc
Sources (1)
- FDA UDI 465e80b1-4e7e-437b-9490-40d2909dedff 33 fields · synced May 30, 2026