Identity
- Trade Name
- HCG dipstick Test FDA UDI
- Generic Name
- Human chorionic gonadotropin beta-subunit/follicle stimulating hormone IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- This is a test for the qualitative detection of human Chorionic Gonadotropin (HCG) in urine. FDA UDI
- Model / Reference
- RAP-2818 FDA UDI
- Description
- This is a test for the qualitative detection of human Chorionic Gonadotropin (HCG) in urine. FDA UDI
Identifiers
- Catalog Number
- RAP-2818 FDA UDI
- Primary DI / UDI-DI
- 00840239028181 FDA UDI
- FDA Product Code
- JHI FDA UDI
- GMDN Term
- Human chorionic gonadotropin beta-subunit/follicle stimulating hormone IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1155 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
HCG dipstick Test by DRG International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- DRG International, Inc.
Sources (1)
- FDA UDI eb5e3bd5-6172-42d3-8ec8-5fd63a9ec13c 36 fields · synced May 30, 2026