FDA.reportPublic FDA data

Superbio Immunofluorescence Analyzer

Primary DI
06974521002246
Brand
Superbio Immunofluorescence Analyzer
Company
Shenzhen Superbio Technology Co., Ltd.
Model
EASY-11
Catalog number
SUPE01106
Published
2023-03-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe

Product Codes#

Code, Name table
CodeName
KHOFluorometer, For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHOFluorometer, For Clinical UseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220046000Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11Shenzhen Superbio Technology Co., Ltd.2022-12-13DJG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974521002246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974521002246069745210022466974521002246

GMDN Terms#

Term, Definition table
TermDefinition
Fluorescent immunoassay analyser IVD, laboratoryAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from an immunological reaction between the reagents and the specimen, and typically includes an autosampler, reagent dispenser, light source, filter or monochromator, a fluorescent detection system (fluorometer or spectrofluorometer), data processing and/or data display software.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
724542368
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974521002239S-Trust Fentanyl Urine Detection Kit (Fluorescence Immunochromatographic Assay)25 Tests/KitSUPF0650252023-03-22
06974521006619U-Catch Fentanyl Urine Detection Kit (Fluorescence Immunochromatographic Assay)25 Tests/KitYRLF0650252023-03-22
06974521006626Bioeasy Immunofluorescence AnalyzerEASY-11YRLE011062023-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850076346010HealgenHEALGEN LIFE SCIENCE, LLCKHO2026-02-06
10850076346017HealgenHEALGEN LIFE SCIENCE, LLCKHO2026-02-06
05430003908761SEEKER®Lacar MDX TechnologiesKHO2026-01-15
07649996894014abioSCOPEAbionic SAKHO2025-02-18
06974849369380Macro & Micro-Test Fluorescence Immunoassay AnalyzerJiangsu Macro & Micro-Test Med-Tech Co., Ltd.KHO2024-09-19
06974849369397Macro & Micro-Test Fluorescence Immunoassay AnalyzerJiangsu Macro & Micro-Test Med-Tech Co., Ltd.KHO2024-09-19
08809317541259FREND SystemNanoEnTek, Inc.KHO2024-06-30
08800066300104ASFA® SCANNERMBD CO., Ltd.KHO2023-11-21
06974521006626Bioeasy Immunofluorescence AnalyzerShenzhen Superbio Technology Co., Ltd.KHO2023-03-22
00817302022339Carolina Liquid Chemistries Corp. Immunofluorescence Analyzer RYANCAROLINA LIQUID CHEMISTRIES CORPORATIONKHO2023-03-10
06974849369298Immunofluorescence ReaderJiangsu Macro & Micro-Test Med-Tech Co., Ltd.KHO2022-12-06
06438147335008AutoDELFIA Automatic Immunoassay SystemWallac OyKHO2022-08-11
06438147335022AutoDELFIA Automatic Immunoassay SystemWallac OyKHO2022-08-11
09120052070521INFINITE 200 PROTecan Austria GmbHKHO2021-06-22
04897078440045ALiA FIA AnalyserSANWA BIOTECH LIMITEDKHO2021-01-27
04897078440052Ariel Fluorescent Immunoassay SystemSANWA BIOTECH LIMITEDKHO2021-01-27
04897078440106Thetis Fluorescent Immunoassay SystemSANWA BIOTECH LIMITEDKHO2021-01-27
30014613336341SofiaQUIDEL CORPORATIONKHO2020-10-21
30014613336648SofiaQUIDEL CORPORATIONKHO2020-10-21
10758750000272VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KHO2020-07-31
10758750001040VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KHO2020-07-31
10758750011308VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KHO2020-07-31
06970136030100NAGuangzhou Labsim Biotech Co., LtdKHO2020-05-20
06970136030216NAGuangzhou Labsim Biotech Co., LtdKHO2020-05-20
08800066300005ASFA SCANNERMBD CO., Ltd.KHO2020-01-29
04560189282896AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360TOSOH CORPORATIONKHO2019-09-02
04560189283992AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-900TOSOH CORPORATIONKHO2019-09-02
045601892840059tray SorterTOSOH CORPORATIONKHO2019-09-02
0456018928401219tray SorterTOSOH CORPORATIONKHO2019-09-02
04560189284616AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-2000 STTOSOH CORPORATIONKHO2019-09-02