Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- TEST,HCG,PREGNANCY,URINE,STRIP,25 MIU FDA UDI
- Model / Reference
- MPH11325HCG FDA UDI
- Description
- TEST,HCG,PREGNANCY,URINE,STRIP,25 MIU FDA UDI
Identifiers
- Catalog Number
- MPH11325HCG FDA UDI
- Primary DI / UDI-DI
- 20888277703565 FDA UDI
- 510(k) Number
- K043443 FDA UDI
- FDA Product Code
- LCX FDA UDIJHI 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
Yes
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
Medline by Medline Industries, Inc. — Class II — 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
K043443 also covers:
- The Babydust Method — BABYDUST METHOD LLC, THE
- Dealmed — DEALMED MEDICAL SUPPLIES LLC
- Easy@Home Pregnancy Test (10 HCG Midstreams) — EASY HEALTHCARE CORPORATION
- Easy@Home Pregnancy Test (10 HCG strips) — EASY HEALTHCARE CORPORATION
- Easy@Home Pregnancy Test (10 HCG strips) — EASY HEALTHCARE CORPORATION
- Easy@Home Pregnancy Test (100 HCG strips) — EASY HEALTHCARE CORPORATION
- Easy@Home Pregnancy Test (20 HCG strips +20 cups) — EASY HEALTHCARE CORPORATION
- Easy@Home Pregnancy Test (20 HCG strips) — EASY HEALTHCARE CORPORATION
- Easy@Home Pregnancy Test (20 HCG strips) — EASY HEALTHCARE CORPORATION
- Easy@Home Pregnancy Test (25 HCG strips) — EASY HEALTHCARE CORPORATION
- Easy@Home Pregnancy Test (25 HCG strips) — EASY HEALTHCARE CORPORATION
- Easy@Home Pregnancy Test (3 HCG Midstreams) — EASY HEALTHCARE CORPORATION
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
- Medline Industries, Inc.
Sources (1)
- FDA UDI 07f0bec4-3eab-4281-9afe-4dd8f5a06178 37 fields · synced May 30, 2026