FDA.reportPublic FDA data

INFINITE 200 PRO

Primary DI
09120052070521
Brand
INFINITE 200 PRO
Company
Tecan Austria GmbH
Model
30050303 01
Catalog number
30050303
Device description
microplate reader
Published
2021-06-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
KHOFluorometer, For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJQColorimeter, Photometer, Spectrophotometer For Clinical UseClinical Chemistry1
KHOFluorometer, For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09120052070521PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120052070521091200520705219120052070521

GMDN Terms#

Term, Definition table
TermDefinition
Microplate reader IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used to photometrically measure the optical absorbance or emission of clinical specimens in microplates containing multiple individual sample wells, with or without a separate cuvette-reading station. The device utilizes technology which may include reagent dispensing, a single or dual lightsource, bandpass filters, monochromators, photodetectors, data processing software and/or data displays to determine the qualitative and/or quantitative values of biological constituents of a clinical specimen. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18003525128helpdesk-us@tecan.com

Regulatory Flags#

DUNS number
301237509
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
09120052070880MAGELLAN PROMAGELLAN PRO V 7.X2020-01-07
09120052070910MAGELLAN PROMAGELLAN PRO TRACKER V 7.X2020-01-07
09120052070996MAGELLANMAGELLAN V7.X301838892020-12-01
09120052071009MAGELLANMAGELLAN TRACKER V7.X301838902020-12-01
09120052071320USB-STICK MAGELLAN PRO V7.530219868 00302198682023-02-26
09120052071238USB-STICK MAGELLAN V 7.5 SUNRISE+F5030204301 00302043012022-05-26
09120052071504USB-STICK MAGELLAN V 7.530231095 00302310952023-07-07
09120052071184SUNRISE30087502 02300875022023-07-06
09120052071191SUNRISE-RC/ST EVOLYZER30087504 02300875042023-07-06
09120052071207SUNRISE-RC/TW EVOLYZER30087505 02300875052023-07-06
09120052071214SUNRISE-RC/6F EVOLYZER30087506 02300875062023-07-06
09120052071344USB-STICK MAGELLAN PRO V7.530219868 00302198682023-02-26
09120052071351USB-STICK MAGELLAN PRO V7.430220141 00 302201412022-08-17
09120052071146Infinite F50 Plus30183570 00301835702022-05-26
09120052071160Hydroflex Plus30190374 00301903742022-05-26
09120052070453HYDROFLEX ELISA30087532 01300875322020-09-18
09120052070460HYDROFLEX EVOLYZER 8CH30087533 01300875332020-09-18
09120052070477HYDROFLEX EVOLYZER 16CH30087534 01300875342020-09-18
09120052070484HYDROFLEX FOR FREEDOM EVO30087535 01300875352020-09-18
09120052070385SUNRISE-RC/ST EVOLYZER30087504 01300875042020-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814905021479Safe Waste System Spectrophotometer for Pharmaceutical AnalysisCODONICS INC.JJQ2026-04-20
00850076346010HealgenHEALGEN LIFE SCIENCE, LLCKHO2026-02-06
10850076346017HealgenHEALGEN LIFE SCIENCE, LLCKHO2026-02-06
05430003908761SEEKER®Lacar MDX TechnologiesKHO2026-01-15
05430003908815SEEKER®Lacar MDX TechnologiesJJQ2026-01-15
00850049545501Diagnostic Automation, Inc.Diagnostic Automation, Inc.JJQ2025-12-24
07649996894014abioSCOPEAbionic SAKHO2025-02-18
00860011967750ZELLECHEM 200STERILE SAFEQUIP & CHEMICALS LLPJJQ2024-10-01
00816467020396FastPack® IP SystemQUALIGEN INC.JJQ2024-09-27
00816467020402FastPack® IP SystemQUALIGEN INC.JJQ2024-09-27
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
00816870020006NeoLumax CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020013LuMatic CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020051NeoEldex ELISA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020068PrisMatic ELISA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020075Autoplex G1 ELISA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020082Autoplex G2 ELISA + CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870024448Autoplex G3 ELISA + CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
07290016923063Auto Sampler (for BreathID Hp Lab System)MERIDIAN BIOSCIENCE ISRAEL LTDJJQ2024-07-22
07290016923384BreathID Hp Lab DeviceMERIDIAN BIOSCIENCE ISRAEL LTDJJQ2024-07-22
07290016923391BreathID Hp Lab Device (WIN)MERIDIAN BIOSCIENCE ISRAEL LTDJJQ2024-07-22
00860011967743ZELLECHEM-PROSTERILE SAFEQUIP & CHEMICALS LLPJJQ2024-07-09
08809317541259FREND SystemNanoEnTek, Inc.KHO2024-06-30
08800066300104ASFA® SCANNERMBD CO., Ltd.KHO2023-11-21
04048474052527DRG:HYBRiD.XL®DRG Instruments Gesellschaft mit beschränkter HaftungJJQ2023-09-02
00840239052520DRG:HYBRiD.XL®DRG International IncJJQ2023-08-26
10810138822705EndocatorEndo Direct LLCJJQ2023-07-16
09120052071184SUNRISETecan Austria GmbHJJQ2023-07-06
09120052071191SUNRISE-RC/ST EVOLYZERTecan Austria GmbHJJQ2023-07-06