FDA.reportPublic FDA data

XPER Technology Procheck Witty Procheck Smart B-Ketone Test Strips

Primary DI
04719893233841
Brand
XPER Technology Procheck Witty Procheck Smart B-Ketone Test Strips
Company
TAIDOC TECHNOLOGY CORPORATION
Model
TD-4631
Published
2025-10-30
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
JINNitroprusside, Ketones (Urinary, Non-Quant.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JINNitroprusside, Ketones (Urinary, Non-Quant.)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719893233841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719893233841047198932338414719893233841

GMDN Terms#

Term, Definition table
TermDefinition
Ketone (acetoacetate) 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 qualitative and/or quantitative detection of ketone (acetoacetate) in a clinical specimen.

Regulatory Flags#

DUNS number
658530993
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719893233827XPER Technology Procheck Witty Procheck Smart Blood Glucose Test StripsTD-43352025-10-30
04719893237139TD-5052 AKTIVSAFE LANCET (Sterile) (21G) (100PCS/BOX)TD-50522025-11-25
04719893237153TD-5052 AKTIVSAFE LANCET (Sterile) (26G) (100PCS/BOX)TD-50522025-11-25
04719893237177TD-5052 AKTIVSAFE LANCET (Sterile) (30G) (100PCS/BOX)TD-50522025-11-25
04710469874642Uright TD-1242 Forehead ThermometerTD-1242A2025-10-30
04710469879548XPER Technology Multi-Functional Monitoring System Procheck SmartTD-41402025-10-30
04710469879555XPER Technology Multi-Functional Monitoring System Procheck WittyTD-41432025-10-30
04710636645921MbH (Mobile Health) TD-3140 Blood Pressure TD-31402025-10-30
04719893233834XPER Technology Procheck Witty Procheck Smart Total Cholesterol Test StripsTD-46422025-10-30
04710469874635CLEVER TD-1242 Forehead ThermometerTD-1242B2025-10-29
04713106028187URIGHT Hemoglobin A1c AnalyzerTD-46112025-03-26
04710469873409Forehead Thermometer TD-1261TD-12612020-02-20
04710636640162TD-THIN Sterile Lancets (100pcs/box)TD-50842023-08-31
04717095034143MbH Fingertip Pulse OximeterTD-82552020-05-15
04710469873973CLEVER TD-1242 FOREHEAD THERMOMETERTD-12422021-10-28
04710469874581DIRECT SUPPLY Attendant ACTT-1 Tympanic ThermometerTD-11072020-06-01
04710469874598DIRECT SUPPLY Attendant Tympanic Thermometer Probe Cover (300pce/Box)TD-11072020-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.JIN2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.JIN2026-04-16
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2026-04-16
00816042016417FORAFORA CARE INC.JIN2026-03-20
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
00860015091642KetoBMKETOBM USA LLCJIN2026-01-19
00199284689879SureMediks B-Ketone Test Strips (25pcs/box)Rasimo Systems LLCJIN2025-12-05
04710469879548XPER Technology Multi-Functional Monitoring System Procheck SmartTAIDOC TECHNOLOGY CORPORATIONJIN2025-10-30
04710469879555XPER Technology Multi-Functional Monitoring System Procheck WittyTAIDOC TECHNOLOGY CORPORATIONJIN2025-10-30
00850014861681heartscare B-Ketone Test Strips (10pcs/Box)Hearts Bio, Inc.JIN2025-10-01
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIN2025-09-18
00850014861575HeartsCare C1 Plus Multi-Functional Monitoring SystemHearts Bio, Inc.JIN2025-07-02
00850014861056HeartsCare C1 Plus Multi-Functional Monitoring SystemHearts Bio, Inc.JIN2025-03-31
00816042015199FORAFORA CARE INC.JIN2025-03-14
80816042015195FORAFORA CARE INC.JIN2025-03-14
00850054026729QMedix™Diagnostic Automation, Inc.JIN2024-10-29
00816042015069FORAFORA CARE INC.JIN2024-10-01
00816042015076FORAFORA CARE INC.JIN2024-10-01
80816042015065FORAFORA CARE INC.JIN2024-10-01
80816042015072FORAFORA CARE INC.JIN2024-10-01
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2024-06-14
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJIN2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJIN2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJIN2024-06-04
00816042015182FORAFORA CARE INC.JIN2024-04-19
80816042015188FORAFORA CARE INC.JIN2024-04-19
08806141303497One+Step 10ADFI CO.,LTDJIN2023-10-16