FDA.reportPublic FDA data

HeartsCare C1 URIC ACID TEST STRIPS(10PCS/BOX)

Primary DI
00850014861353
Brand
HeartsCare C1 URIC ACID TEST STRIPS(10PCS/BOX)
Company
Hearts Bio, Inc.
Model
TD-4289
Published
2023-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00850014861353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850014861353008500148613538500148613530850014861353

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
085509873
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014861834heartscare Total Cholesterol Test Strip (10pcs/box)TD-42892026-04-17
00850014861629HeartsCare BLOOD GLUCOSE TEST STRIPS (50PCS/BOX)TD-42892025-03-31
00850014861681heartscare B-Ketone Test Strips (10pcs/Box)TD-42892025-10-01
00850014861575HeartsCare C1 Plus Multi-Functional Monitoring SystemTD-42892025-07-02
00850014861056HeartsCare C1 Plus Multi-Functional Monitoring SystemTD-42892025-03-31
00850014861407HeartsCare LACTATE TEST STRIPS (10PCS/BOX)TD-42892024-07-08
00850014861537HeartsCare LACTATE TEST STRIPS (25PCS/BOX)TD-42892024-07-08
00850014861360HeartsCare C1 LACTATE TEST STRIPS (10PCS/BOX)TD-42892023-08-08
00850014861049HeartsCare C1 monitoring systemTD-42892022-01-26
00850014861346HeartsCare C1 Total Cholesterol Test Strip (10pcs/box)TD-42892022-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816042014475FORAFORA CARE INC.LFQ2023-10-31
00816042014116FORAFORA CARE INC.LFQ2023-06-26
00816042014192FORAFORA CARE INC.LFQ2023-06-26
00816042014109FORAFORA CARE INC.LFQ2023-06-26
80816042014112FORAFORA 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