FDA.reportPublic FDA data

FORA

Primary DI
80816042015256
Brand
FORA
Company
FORA CARE INC.
Model
6 Connect/Test N'GO Advance/Test N'GO Advance Voic
Device description
Uric Acid Test Strip
Published
2024-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
PTCUric Acid Test System For At Home Prescription Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTCUric Acid Test System For At Home Prescription UseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181675000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181675000FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring SystemTaidoc Technology Corporation2018-12-10PTC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816042015250PrimaryGS10
80816042015256Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816042015250008160420152508160420152500816042015250
8081604201525680816042015256

GMDN Terms#

Term, Definition table
TermDefinition
Uric acid IVD, reagentA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
004340807
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816042014543FORATest N'GO Advance Voice2025-05-06
00816042015045FORASpiro10b2026-05-18
00816042015052FORASpiro10b2026-05-18
00816042016417FORAGTel/Test N'GO Advance/Test N’GO Advance Voice/Tes2026-03-20
00816042016387FORATest N'GO Advance/Test N'GO Advance Voice2026-04-27
00816042013577FORAGTel/Test N'GO Advance/Test N'GO Advance Voice/Goj2020-12-22
00816042013669FORATest N'GO Advance Pro 2020-05-05
00816042013881ForaCareGD202020-04-06
00816042013911FORAG202023-07-03
00816042015038FORAGTel/Test N'GO Advance/Test N'GO Advance Voice/Tes2024-10-01
00816042013850FORA 6 Connect2020-02-17
00816042010200FORAV10/D10/D202016-12-20
00816042010675FORAV30/G30/Premium V102016-11-15
00816042010828ForaCareGD202017-04-03
00816042010859Pet GlucoPet Gluco2018-08-07
00816042011221FORAGD502017-04-04
00816042011610FORAG20/D302017-05-09
00816042011634FORAMD2017-06-13
00816042011665FORAD40/G312017-05-16
00816042011672FORAV30/G30/Premium V102017-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816042015250FORAFORA CARE INC.PTC2024-09-23
00886338000048UASure II Blood Uric Acid Test Strips 25sAPEX BIOTECHNOLOGY CORP.PTC2021-12-27
00886338000031UASure II Blood Uric Acid Monitoring SystemAPEX BIOTECHNOLOGY CORP.PTC2021-12-27