Home GUDID 06974849369397 Macro & Micro-Test Fluorescence Immunoassay Analyzer
Primary DI 06974849369397
Brand Macro & Micro-Test Fluorescence Immunoassay Analyzer
Company Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Model HWTS-IF2000
Published 2024-09-19
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name KHO Fluorometer, For Clinical Use
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KHO Fluorometer, For Clinical Use Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 06974849369397 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 06974849369397 06974849369397 6974849369397
GMDN Terms# Term, Definition table Term Definition Fluorescent immunoassay analyser IVD, laboratory An 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.
Regulatory Flags# DUNS number 560300737 Device count 1 Premarket exempt true Lot or batch true Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 06974849369403 EudemonTM AIO800 HWTS-AIO800 HWTS-EQ055 2024-11-14 06974849369076 Easy Amp Real-time Fluorescence Isothermal Detection System HWTS-1600S 2022-12-06 06974849369083 Easy Amp Real-time Fluorescence Isothermal Detection System HWTS-1600P 2022-12-06 06974849369380 Macro & Micro-Test Fluorescence Immunoassay Analyzer HWTS-IF1000 2024-09-19 06974849369304 Macro & Micro-Test HCG Pregnancy Test Midstream 1 test/kit 2023-11-27 06974849369311 Macro & Micro-Test HCG Pregnancy Test Midstream 20 tests/kit 2023-11-27 06974849369328 Macro & Micro-Test HCG Pregnancy Test Midstream 3 tests/kit 2023-11-27 06974849369335 Macro & Micro-Test HCG Pregnancy Test Midstream 5 tests/kit 2023-11-27 06974849369342 Macro & Micro-Test LH Test 1 test/kit 2023-11-27 06974849369359 Macro & Micro-Test LH Test 3 tests/kit 2023-11-27 06974849369366 Macro & Micro-Test LH Test 5 tests/kit 2023-11-27 06974849369373 Macro & Micro-Test LH Test 20 tests/kit 2023-11-27 06974849369007 Macro & Micro-Test Viral DNA/RNA Kit 50 tests/kit 2022-12-06 06974849369014 Macro & Micro-Test Viral DNA/RNA Kit 32 tests/kit 2022-12-06 06974849369021 Macro & Micro-Test Viral DNA/RNA Kit 48 tests/kit 2022-12-06 06974849369038 Macro & Micro-Test Viral DNA/RNA Kit 96 tests/kit 2022-12-06 06974849369045 Macro & Micro-Test Sample Release Reagent 50 tests/kit 2022-12-06 06974849369052 Macro & Micro-Test Automatic Nucleic Acid Extractor HWTS-NPure32 2022-12-06 06974849369069 Macro & Micro-Test Sample Collecting, Mailing & Shipping Kit 50 tubes/kit 2mL 2022-12-06 06974849369090 Macro & Micro-Test Sample Collecting, Mailing & Shipping Kit 50 tubes/kit 3mL 2022-12-06
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850076346010 Healgen HEALGEN LIFE SCIENCE, LLC KHO 2026-02-06 10850076346017 Healgen HEALGEN LIFE SCIENCE, LLC KHO 2026-02-06 05430003908761 SEEKER® Lacar MDX Technologies KHO 2026-01-15 07649996894014 abioSCOPE Abionic SA KHO 2025-02-18 06974849369380 Macro & Micro-Test Fluorescence Immunoassay Analyzer Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. KHO 2024-09-19 08809317541259 FREND System NanoEnTek, Inc. KHO 2024-06-30 08800066300104 ASFA® SCANNER MBD CO., Ltd. KHO 2023-11-21 06974521002246 Superbio Immunofluorescence Analyzer Shenzhen Superbio Technology Co., Ltd. KHO 2023-03-22 06974521006626 Bioeasy Immunofluorescence Analyzer Shenzhen Superbio Technology Co., Ltd. KHO 2023-03-22 00817302022339 Carolina Liquid Chemistries Corp. Immunofluorescence Analyzer RYAN CAROLINA LIQUID CHEMISTRIES CORPORATION KHO 2023-03-10 06974849369298 Immunofluorescence Reader Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. KHO 2022-12-06 06438147335008 AutoDELFIA Automatic Immunoassay System Wallac Oy KHO 2022-08-11 06438147335022 AutoDELFIA Automatic Immunoassay System Wallac Oy KHO 2022-08-11 09120052070521 INFINITE 200 PRO Tecan Austria GmbH KHO 2021-06-22 04897078440045 ALiA FIA Analyser SANWA BIOTECH LIMITED KHO 2021-01-27 04897078440052 Ariel Fluorescent Immunoassay System SANWA BIOTECH LIMITED KHO 2021-01-27 04897078440106 Thetis Fluorescent Immunoassay System SANWA BIOTECH LIMITED KHO 2021-01-27 30014613336341 Sofia QUIDEL CORPORATION KHO 2020-10-21 30014613336648 Sofia QUIDEL CORPORATION KHO 2020-10-21 10758750000272 VITROS ORTHO-CLINICAL DIAGNOSTICS, INC. KHO 2020-07-31 10758750001040 VITROS ORTHO-CLINICAL DIAGNOSTICS, INC. KHO 2020-07-31 10758750011308 VITROS ORTHO-CLINICAL DIAGNOSTICS, INC. KHO 2020-07-31 06970136030100 NA Guangzhou Labsim Biotech Co., Ltd KHO 2020-05-20 06970136030216 NA Guangzhou Labsim Biotech Co., Ltd KHO 2020-05-20 08800066300005 ASFA SCANNER MBD CO., Ltd. KHO 2020-01-29 04560189282896 AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360 TOSOH CORPORATION KHO 2019-09-02 04560189283992 AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-900 TOSOH CORPORATION KHO 2019-09-02 04560189284005 9tray Sorter TOSOH CORPORATION KHO 2019-09-02 04560189284012 19tray Sorter TOSOH CORPORATION KHO 2019-09-02 04560189284616 AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-2000 ST TOSOH CORPORATION KHO 2019-09-02