FDA UDI In Commercial Distribution 🇺🇸 United States

FORA

DI: 00816042014475 · Model: Test N'GO Advance Voice · FORA CARE INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
FORA
Primary DI
00816042014475
Version / Model
Test N'GO Advance Voice
Company Name
FORA CARE INC.
Labeler DUNS
004340807
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-10-31
Public Version
2
Public Version Date
2024-07-19
Public Version Status
Update
Public Device Record Key
b344d0be-62bf-494f-8429-d66f8269ada6

Device Description

Uric Acid Test System

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
Yes
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LFQ Acid, Uric, Acid Reduction Of Ferric Ion

GMDN Terms

Code Name
62221 Uric acid monitoring system IVD, home-use

Identifiers

Type ID
Primary 00816042014475