FDA.reportPublic FDA data

FORA

Primary DI
80816042014112
Brand
FORA
Company
FORA CARE INC.
Model
6 Connect
Device description
Uric Acid Test Strip
Published
2023-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LFQAcid, Uric, Acid Reduction Of Ferric Ion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFQAcid, Uric, Acid Reduction Of Ferric IonClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816042014116PrimaryGS10
80816042014112Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816042014116008160420141168160420141160816042014116
8081604201411280816042014112

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
true
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
00816042014475FORAFORA CARE INC.LFQ2023-10-31
00850014861353HeartsCare C1 URIC ACID TEST STRIPS(10PCS/BOX)Hearts Bio, Inc.LFQ2023-08-08
00816042014116FORAFORA CARE INC.LFQ2023-06-26
00816042014192FORAFORA CARE INC.LFQ2023-06-26
00816042014109FORAFORA CARE INC.LFQ2023-06-26
00816042014185FORAFORA CARE INC.LFQ2023-06-26
80816042014198FORAFORA CARE INC.LFQ2023-06-26
06971404131611Uric Acid Control solution(level 1)e-Linkcare Meditech Co., LtdLFQ2022-05-17
06971404131628Uric Acid Control solution(level 2)e-Linkcare Meditech Co., LtdLFQ2022-05-17
00886338000031UASure II Blood Uric Acid Monitoring SystemAPEX BIOTECHNOLOGY CORP.LFQ2021-12-27
00886338000062UASure II Blood Uric Acid Test Strips 25sAPEX BIOTECHNOLOGY CORP.LFQ2021-12-27
16971404130949Blood Uric Acid Test Stripse-Linkcare Meditech Co., LtdLFQ2021-12-17
06971404130928Blood Uric Acid Monitoring Systeme-Linkcare Meditech Co., LtdLFQ2021-12-17
16971404130925Blood Uric Acid Monitoring Systeme-Linkcare Meditech Co., LtdLFQ2021-12-17
26971404130946Blood Uric Acid Test Stripse-Linkcare Meditech Co., LtdLFQ2021-12-17
04713648766462UASure Blood Uric Acid Monitoring Meter APEX BIOTECHNOLOGY CORP.LFQ2020-05-11
04713648766479UASure Blood Uric Acid Test StripAPEX BIOTECHNOLOGY CORP.LFQ2020-05-11