FDA.reportPublic FDA data

Sciteck

Primary DI
00854080008612
Brand
Sciteck
Company
Sciteck Diagnostics, Inc.
Model
AUA-450
Catalog number
AUA-450
Published
2026-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KQOAutomated Urinalysis System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQOAutomated Urinalysis SystemClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854080008612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854080008612008540800086128540800086120854080008612

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyser IVD, laboratoryAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technologies (e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence). Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes.

Regulatory Flags#

DUNS number
041137964
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854080008629AutoUA® 200-60200-602026-04-07
00854080008643AutoUA®217-S217-S2026-04-07
00854080008650AutoUA®200-120200-1202026-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.KQO2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.KQO2026-04-16
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.KQO2026-04-16
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.KQO2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.KQO2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.KQO2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.KQO2026-02-06
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.KQO2025-09-18
04987486005292Concentrated Washing Solution 3ARKRAY USA, INC.KQO2024-12-02
00015482117344AUTION™ Sticks 9EB - Test StripsARKRAY USA, INC.KQO2024-12-02
00015482181550AUTION EYE™ Sheath Solution - 10L BottleARKRAY USA, INC.KQO2024-12-02
00015482181574AUTION EYE™ Control Solution H/LARKRAY USA, INC.KQO2024-12-02
00015482181598AUTION EYE™ Calibrator Focus/CalibratorARKRAY USA, INC.KQO2024-12-02
14987486005299Concentrated Washing Solution 3ARKRAY USA, INC.KQO2024-12-02
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.KQO2024-06-14
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSKQO2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSKQO2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSKQO2024-06-04
20682607200508MISSION U500 URINE ANALYZERAcon Laboratories, Inc.KQO2024-03-08
20682607200515MISSION U500 URINE ANALYZERAcon Laboratories, Inc.KQO2024-03-08
10722066004408Rapid ResponseBTNX IncKQO2023-10-30
10722066004415Rapid ResponseBTNX IncKQO2023-10-30
00657498002094Uri-Trak 120 M Urine AnalyzerSTANBIO LABORATORY, L.P.KQO2023-06-08
17290017272471Minuteful - kidney testHEALTHY.IO LTDKQO2022-11-01
00630414607962Clinitek Status ConnectorSiemens Healthcare Diagnostics Inc.KQO2020-09-30
10885380175596CARDINAL HEALTHCardinal Health 200, LLCKQO2020-07-07
20885380175548CARDINAL HEALTHCardinal Health 200, LLCKQO2020-06-30
20885380175562CARDINAL HEALTHCardinal Health 200, LLCKQO2020-06-30
08800068200020My YodocS-CONNECT CO.,LTDKQO2020-04-10
08800068200006My YodocS-CONNECT CO.,LTDKQO2020-04-09