FDA UDI
In Commercial Distribution
🇺🇸 United States
FORA
DI: 00816042015250
·
Model: 6 Connect/Test N'GO Advance/Test N'GO Advance Voice
·
FORA CARE INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- FORA
- Primary DI
- 00816042015250
- Version / Model
- 6 Connect/Test N'GO Advance/Test N'GO Advance Voice
- Company Name
- FORA CARE INC.
- Labeler DUNS
- 004340807
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2024-09-23
- Public Version
- 1
- Public Version Date
- 2024-10-01
- Public Version Status
- New
- Public Device Record Key
- 83b6865b-abcd-4ac7-b593-354ccc6b4b51
Device Description
Uric Acid Test Strip
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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 |
|---|---|---|---|---|
| PTC | Uric Acid Test System For At Home Prescription Use | Clinical Chemistry | 862.1775 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53586 | Uric acid IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of uric acid in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 80816042015256 | GS1 | ||||
| Primary | 00816042015250 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181675 | 000 |