Identity
- Trade Name
- FORA FDA UDI
- Generic Name
- Multiple clinical chemistry analyte monitoring system IVD, home-use FDA UDI
- Device Name
- Ketone Test Strips FDA UDI
- Model / Reference
- 6 Connect FDA UDI
- Description
- Ketone Test Strips FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816042013089 FDA UDI
- FDA Product Code
- JIN FDA UDI
- GMDN Term
- Multiple clinical chemistry analyte monitoring system IVD, home-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1435 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
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: Multiple clinical chemistry analyte monitoring system IVD, home-use
Fora by Fora Care Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple clinical chemistry analyte monitoring system IVD, home-use.
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- FreeStyle Lite — ABBOTT DIABETES CARE INC · Class II
- Blood Ketone Control solution(level 3) — e-Linkcare Meditech Co., Ltd · Class I
- Blood Glucose Control Solution — STANBIO LABORATORY, L.P. · Class I
- FreeStyle Precision Neo — ABBOTT DIABETES CARE INC · Class II
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 |
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Manufacturer
- Manufacturer
- Fora Care Inc.
Sources (1)
- FDA UDI 87e550d9-42a6-4668-8f1a-f75febdb2a6d 33 fields · synced May 30, 2026