Identity
- Trade Name
- Amazon FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Amazon Basic Care DPS DIG Blue FDA UDI
- Model / Reference
- Digital Pregnancy Test FDA UDI
- Description
- Amazon Basic Care DPS DIG Blue FDA UDI
Identifiers
- Catalog Number
- N/A FDA UDI
- Primary DI / UDI-DI
- 00195515050098 FDA UDI
- 510(k) Number
- K060128 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
Yes
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
Amazon by Amazon.com Services, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K060128 also covers:
- CareOne — Ahold U.S.A., Inc.
- Albertsons — BETTER LIVING BRANDS LLC
- H.E.B — H. E. BUTT GROCERY COMPANY
- H.E.B — H. E. BUTT GROCERY COMPANY
- H.E.B — H. E. BUTT GROCERY COMPANY
- Kroger — KROGER CO., THE
- Kroger — KROGER CO., THE
- Meijer — MEIJER, INC.
- Clearblue — SPD SWISS PRECISION DIAGNOSTICS GMBH
- Equaline — SPD SWISS PRECISION DIAGNOSTICS GMBH
- Equaline Digital Pregnancy Test — SPD SWISS PRECISION DIAGNOSTICS GMBH
- TopCare Health — Topco Associates, LLC
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 |
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Manufacturer
- Manufacturer
- Amazon.com Services, LLC
Sources (1)
- FDA UDI 1e121424-713c-4a6e-bce9-664087b227cd 37 fields · synced May 30, 2026