Identity
- Trade Name
- Rightest FDA UDI
- Generic Name
- Home-use/point-of-care blood glucose monitoring system IVD FDA UDI
- Model / Reference
- GC300 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00883489001047 FDA UDI
- 510(k) Number
- K133003 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Home-use/point-of-care blood glucose monitoring system IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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: Home-use/point-of-care blood glucose monitoring system IVD
Rightest by Bionime Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Home-use/point-of-care blood glucose monitoring system IVD.
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Cleared under the same submission
K133003 also covers:
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
- Bionime Corporation
Sources (1)
- FDA UDI ea18d20a-9eac-4dce-84c8-f6162e6c375a 33 fields · synced May 30, 2026