Identity
- Trade Name
- DAVID FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- The convenience kit is consisiting of 30 ovulation test strips and 10 pregnancy test strips . FDA UDI
- Model / Reference
- 82412 FDA UDI
- Description
- The convenience kit is consisiting of 30 ovulation test strips and 10 pregnancy test strips . FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06938444982412 FDA UDI
- FDA Product Code
- OIE FDA UDI
- GMDN Term
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 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
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinicalNatural conception assistance kit
David by Equinox Biotech Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Natural conception assistance kit.
- Dr. Talbot's — TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS LLC · Class I
- Easy@Home Ovulation Test Kit (50 LH strips + 20 HCG strips ) — EASY HEALTHCARE CORPORATION · Class II
- Topcare — Topco Associates, LLC · Class I
- Easy@Home Ovulation Test Strip (50 tests kit) — EASY HEALTHCARE CORPORATION · Class I
- Medichoice — OWENS & MINOR DISTRIBUTION, INC. · Class II
- Kroger — KROGER CO., THE · Class I
- H.E.B — H. E. BUTT GROCERY COMPANY · Class I
- Equate — Walmart Stores · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Equinox Biotech Co., Ltd.
Sources (1)
- FDA UDI 0b493654-8e4a-47e5-a362-cfc4261c7e6b 34 fields · synced May 30, 2026