FDA UDI
In Commercial Distribution
🇺🇸 United States
FORA
DI: 00816042014543
·
Model: 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
- 00816042014543
- Version / Model
- 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
- 2025-05-06
- Public Version
- 1
- Public Version Date
- 2025-05-14
- Public Version Status
- New
- Public Device Record Key
- b3f1e4c6-13ee-4527-a161-17fa4a8688e9
Device Description
Lactate Test Strip
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| KHP | Acid, Lactic, Enzymatic Method | Clinical Chemistry | 862.1450 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35885 | Lactate monitoring system IVD, home-use | A collection of devices including a dedicated, portable, electrically-powered instrument (self-testing meter) reagents, test strips, and/or other associated disposable materials intended to be used for the quantitative measurement of lactate in a whole blood specimen.; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. It is typically used to monitor physical performance and conditioning in sport, and/or to support patient management. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 80816042014549 | GS1 | ||||
| Primary | 00816042014543 | GS1 |