Identity
- Trade Name
- Walgreens FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- WALG ANALOG OVULATION 10CT + ANALOG PREG TEST 1CT FDA UDI
- Model / Reference
- 116420 FDA UDI
- Description
- WALG ANALOG OVULATION 10CT + ANALOG PREG TEST 1CT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00311917207087 FDA UDI
- 510(k) Number
- K183097 FDA UDI
- FDA Product Code
- CEP FDA UDILCX FDA UDI
- GMDN Term
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1485 FDA UDI862.1155 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
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
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: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Walgreens by Walgreen Co. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical.
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Cleared under the same submission
K183097 also covers:
- CLARISSE — DELTA BRANDS INC.
- Clarisse — DELTA BRANDS INC.
- 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
- MaYa — 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Walgreen Co.
Sources (1)
- FDA UDI 94cbe14a-99c6-4638-babe-9d98c6fbb26b 35 fields · synced Jun 1, 2026