Identity
- Trade Name
- QuickProfile™ HCG Test Strip FDA UDI
- Generic Name
- Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid FDA UDI
- Device Name
- immunochromatographic test (IVD) for Human chorionic gonadotropin beta-subunit (beta-HCG) FDA UDI
- Model / Reference
- 07RD7001 FDA UDI
- Description
- immunochromatographic test (IVD) for Human chorionic gonadotropin beta-subunit (beta-HCG) FDA UDI
Identifiers
- Catalog Number
- 07RD7001 FDA UDI
- Primary DI / UDI-DI
- M90107RD70010 FDA UDI
- 510(k) Number
- K981770 FDA UDI
- FDA Product Code
- JHI FDA UDI
- GMDN Term
- Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid 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
Yes
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
Dimensions & Sizes
- Size
- Length — 72 Millimeter FDA UDI
QuickProfile™ HCG Test Strip by LumiQuick Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid.
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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
- LumiQuick Diagnostics, Inc.
Sources (1)
- FDA UDI 297a3292-d061-47df-a530-bc4111d4aa05 38 fields · synced Jun 9, 2026