FORA

Primary DI
00816042015250
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
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.

Regulatory Flags#

DUNS number
004340807
Device count
10
Lot or batch
true
Expiration date on label
true

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
80816042015256FORAFORA 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