Identity
- Trade Name
- MaYa FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
- Model / Reference
- midstream FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06923304600087 FDA UDI
- 510(k) Number
- K183097 FDA UDI
- FDA Product Code
- LCX FDA UDI
- GMDN Term
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical 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
No
FDA UDI
Category: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
MaYa by Weihai Kangzhou Biotechnology Engineering Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K183097 also covers:
- CLARISSE — DELTA BRANDS INC.
- Clarisse — DELTA BRANDS INC.
- Walgreens — WALGREEN CO.
- FERTICARE — Weihai Kangzhou Biotechnology Engineering Co., Ltd
- FERTICARE — Weihai Kangzhou Biotechnology Engineering Co., Ltd
- INSTANT Aid By PUR-est — Weihai Kangzhou Biotechnology Engineering Co., Ltd
- Oichid — Weihai Kangzhou Biotechnology Engineering Co., Ltd
- PERSONAL CARE — Weihai Kangzhou Biotechnology Engineering Co., Ltd
- SUPER-AID — Weihai Kangzhou Biotechnology Engineering Co., Ltd
- SUPER-AID — Weihai Kangzhou Biotechnology Engineering Co., Ltd
- Universal — Weihai Kangzhou Biotechnology Engineering Co., Ltd
- kangzhou — Weihai Kangzhou Biotechnology Engineering Co., Ltd
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
- Weihai Kangzhou Biotechnology Engineering Co., Ltd
Sources (1)
- FDA UDI 8c84a603-66e6-4e96-8209-b2c03829c0e7 33 fields · synced May 29, 2026