FDA.reportPublic FDA data

Calibrator Solution For Urine Analyzer

Primary DI
06935740750677
Brand
Calibrator Solution For Urine Analyzer
Company
Urit Medical Electronic Co., Ltd.
Model
URIT YC 2ST,C-TUR(2×8mL)
Published
2026-04-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JJWUrinalysis Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJWUrinalysis Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06935740750677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06935740750677069357407506776935740750677

GMDN Terms#

Term, Definition table
TermDefinition
Multiple urine analyte IVD, controlA material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
653742429
Device count
1
Premarket exempt
true
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
06935740750608Urine Reagent StripsURIT 11FA,100 pcs/tube2026-04-16
06935740750615Urine Reagent StripsURIT 12FA ,100 pcs/tube2026-04-16
06935740750622Detergent for Automatic Urine AnalyzerURIT D22,1L2026-04-16
06935740750639Detergent for Automatic Urine AnalyzerURIT D21N,500mL2026-04-16
06935740750646Detergent for Automatic Urine AnalyzerURIT D21,5L2026-04-16
06935740750653Calibrator Solution For Urine AnalyzerURIT YC 2ST,C-SG and C-TUR(C-SG:2×8mL, C-TUR:2×8mL2026-04-16
06935740750660Calibrator Solution For Urine AnalyzerURIT YC 2ST,C-SG(2×8mL)2026-04-16
06935740750684Quality Control Solution For Urine AnalyzerURIT YQ 3STC2026-04-16
06935740750691Quality Control Solution For Urine AnalyzerURIT YQ 3STC,COL(Red:1×8mL,Yellow:1×8mL,Green:1×8m2026-04-16
06935740750707Quality Control Solution For Urine AnalyzerURIT YQ 3STC,TUR(Level 1:1×8mL,Level 2:1×8mL)2026-04-16
06935740750714Quality Control Solution For Urine AnalyzerURIT YQ 3STC,SG(Level 1:1×8mL,Level 2:1×8mL,Level 2026-04-16
06935740750721Urinalysis ControlUQ-14,NO.I:8mL,NO.II:8mL,NO.III:8mL2026-04-16
06935740750738Automatic Urine AnalyzerUC-18002026-04-16
06935740746595MagnifierEX-06 ;1Pc/Box2025-09-22
06935740746601MagnifierEX-06 ;1Pc/Box2025-09-22
06935740726993Hemoglobin Test StripPH 01;25pieces/vial×2/box2024-09-20
06935740733755Automatic Urine AnalyzerUC-18002024-06-14
06935740726986Blood Lipid Test StripPFS 30,10strips/vial×2/box2024-07-12
06935740727006Uric Acid Test StripPA 11,25strips/vial×2/box2024-07-12
06935740727013Uric Acid Test StripPA 16,25strips/vial×2/box2024-07-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740750653Calibrator Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750660Calibrator Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750684Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750691Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750707Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750714Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750721Urinalysis ControlUrit Medical Electronic Co., Ltd.JJW2026-04-16
00682607200672Mission Liquid Urine ControlsAcon Laboratories, Inc.JJW2025-04-17
00682607200689Mission Liquid Urine ControlsAcon Laboratories, Inc.JJW2025-04-17
00682607200696Mission Liquid Urine ControlsAcon Laboratories, Inc.JJW2025-04-17
00682607200702Mission Liquid Urine ControlsAcon Laboratories, Inc.JJW2025-04-17
20682607200676Mission Liquid Urine ControlsACON LABORATORIES, INC.JJW2025-04-17
20682607200683Mission Liquid Urine ControlsACON LABORATORIES, INC.JJW2025-04-17
20682607200690Mission Liquid Urine ControlsACON LABORATORIES, INC.JJW2025-04-17
20682607200706Mission Liquid Urine ControlsACON LABORATORIES, INC.JJW2025-04-17
07290012140136QwikCheck BeadsM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.JJW2023-06-08
07290012140600QwikCheck Beads Proficiency and Training KitM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.JJW2023-06-08
07290016650020QwikCheck Beads Precision and Linearity kitM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.JJW2023-06-08
00896863002424Chromascopics Control Level 1&2 Set 2x25mL (International)QUANTIMETRIX CORPORATIONJJW2023-05-04
06972428161400U-CatchShenzhen Bioeasy Biotechnology Co., LtdJJW2022-12-08
04987562408528UF II CONTROLSYSMEX CORPORATIONJJW2022-11-30
04987562433469UC CONTROLSYSMEX CORPORATIONJJW2022-11-30
04987562433681UF-CONTROLSYSMEX CORPORATIONJJW2022-11-30
05055273207583URINALYSIS CONTROL - LEVEL 1 (URNAL CONTROL 1)RANDOX LABORATORIES LIMITEDJJW2022-10-05
05055273207590URINALYSIS CONTROL - LEVEL 2 (URNAL CONTROL 2)RANDOX LABORATORIES LIMITEDJJW2022-10-05
00850015517198SiemensKOVA INTERNATIONAL, INC.JJW2022-03-03
00850015517204SiemensKOVA INTERNATIONAL, INC.JJW2022-03-03
00850015517211SiemensKOVA INTERNATIONAL, INC.JJW2022-03-03
00847661000549LiquichekBIO-RAD LABORATORIES, INC.JJW2020-09-14
00847661000556LiquichekBIO-RAD LABORATORIES, INC.JJW2020-09-14