FDA UDI
In Commercial Distribution
🇺🇸 United States
RIGHTEST Control Solution GC700
DI: 00883489002631
·
Model: GC700
·
BIONIME CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- RIGHTEST Control Solution GC700
- Primary DI
- 00883489002631
- Version / Model
- GC700
- Company Name
- BIONIME CORPORATION
- Labeler DUNS
- 658637244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-17
- Public Version
- 1
- Public Version Date
- 2025-10-27
- Public Version Status
- New
- Public Device Record Key
- 67676406-f1f6-4baa-8e25-2aa874928437
Device Description
Level 2
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41819 | Glucose IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00883489002648 | GS1 | paper box | 1 | In Commercial Distribution | |
| Primary | 00883489002631 | GS1 | ||||
| Package | 10883489002645 | GS1 | inner carton | 120 | In Commercial Distribution | |
| Package | 20883489002642 | GS1 | outer carton | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- 1 888 481 8485
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190564 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 39 – 86 Degrees Fahrenheit