FDA.reportPublic FDA data

vChem®

Primary DI
10837461002536
Brand
vChem®
Company
IRIS INTERNATIONAL, INC.
Model
vChem®10 SG Urine Chemistry Strips
Catalog number
800-7007
Device description
vChem®10 SG Urine Chemistry Strips
Published
2016-09-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)Clinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10837461002536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1083746100253610837461002536

GMDN Terms#

Term, Definition table
TermDefinition
Multiple urine analyte IVD, kit, colorimetric dipstick, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes within a short period relative to standard laboratory testing procedures, using a colorimetric dipstick (strip) method. This test is commonly used in the laboratory or in point-of-care analyses to screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
098240690
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10837461001973IRISpecCA/CB Twinset800-72112016-09-07
10837461002116iQ®200 iQ® Lamina™ Case of 4 x 7 L800-31022016-09-07
10837461008002AX-4280Specific Gravity Calibrator Set (NA)800-35172016-09-07
10873037000766StatSpinX00-003808-001X00-003808-0012016-09-24
10837461002192iQ®200 iQ® Lamina™ Cradle800-31052016-09-07
10837461002529iChemiChem®10SG Urine Chemistry Strips800-70052016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.JIL2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.JIL2026-04-16
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIL2026-04-16
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIL2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIL2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIL2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIL2026-02-06
00015482104658AUTION MAX™ AX-4060 AnalyzerARKRAY USA, INC.JIL2025-11-07
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIL2025-09-18
00015482117313AUTION MAX™ AX-4060 AnalyzerARKRAY USA, INC.JIL2024-12-02
00850054026729QMedix™Diagnostic Automation, Inc.JIL2024-10-29
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIL2024-06-14
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJIL2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJIL2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJIL2024-06-04
10673486002416Teco Diagnostics Urine Reagent Strips (URS-1G)TECO DIAGNOSTICSJIL2024-03-22
00657498002094Uri-Trak 120 M Urine AnalyzerSTANBIO LABORATORY, L.P.JIL2023-06-08
10888277720336MedlineMEDLINE INDUSTRIES, INC.JIL2022-12-10
10884389181966MedlineMEDLINE INDUSTRIES, INC.JIL2022-10-28
40612479183627McKessonMCKESSON MEDICAL-SURGICAL INC.JIL2022-07-28
10884389181973MedlineMEDLINE INDUSTRIES, INC.JIL2022-04-13
10884389181959MedlineMEDLINE INDUSTRIES, INC.JIL2021-09-16
00722066005255Rapid ResponseBTNX IncJIL2020-12-14
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJIL2020-09-22
10888277110403MedlineMEDLINE INDUSTRIES, INC.JIL2020-08-21
10885380175589CARDINAL HEALTHCardinal Health 200, LLCJIL2020-07-09
20885380175548CARDINAL HEALTHCardinal Health 200, LLCJIL2020-06-30
20885380175555CARDINAL HEALTHCardinal Health 200, LLCJIL2020-06-30
20885380175579CARDINAL HEALTHCardinal Health 200, LLCJIL2020-06-30
08806141302070CYBOW 10DFI CO.,LTDJIL2020-06-29