FDA.reportPublic FDA data

Thermo Scientific

Primary DI
10850044310231
Brand
Thermo Scientific
Company
Thermo Electron LED GmbH
Model
Thermo Scientific X4T IVD-MD
Catalog number
75007340
Device description
Thermo ScientificX4T IVD-MD, 120V
Published
2025-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850044310231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085004431023110850044310231

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose centrifuge IVDAn electrically-powered device intended to be used to separate the components of multiple types and various volumes of clinical suspensions using centrifugal force. It is a self-contained unit with an electric motor, a vertical shaft, and a horizontal rotor attached to the upper end. It is typically used to centrifuge various types of clinical specimens, either alone or after addition of reagents or other additives, for subsequent in vitro diagnostic analysis. It may additionally have refrigeration capabilities to perform temperature-sensitive procedures.

Contacts#

Phone, Email table
PhoneEmail
+496184906000marilyn.barry@thermofisher.com

Regulatory Flags#

DUNS number
537396330
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
10850044310262Thermo ScientificThermo Scientific MT 17 IVD-MD750025772026-05-21
10850044310279Thermo ScientificThermo Scientific MT 17 IVD-MD750025782026-05-21
10850044310309Thermo ScientificThermo Scientific MT 21 IVD-MD750025802026-05-21
10850044310323Fisher ScientificFisherbrand accuSpin 17-HC750025282026-04-22
10850044310347Fisher ScientificFisherbrand accuSpin 17R-HC750025292026-04-22
10850044310354Fisher ScientificFisherbrand accuSpin 21-HC750025302026-04-22
10850044310422Fisher ScientificFisherbrand accuSpin 21R-HC750025312026-04-22
10850044310224Thermo ScientificThermo Scientific S4T IVD-MD750073322026-04-02
10850044310248Thermo ScientificThermo Scientific X4T IVD-MD750073412026-04-02
10850044310255Thermo ScientificThermo Scientific MT 17 IVD-MD750025762026-03-10
10850044310286Thermo ScientificThermo Scientific MT 17 IVD-MD750025982026-03-10
10850044310293Thermo ScientificThermo Scientific MT 21 IVD-MD750025792026-03-10
10850044310378Thermo ScientificThermo Scientific MTR 17 IVD-MD750025882026-03-10
10850044310392Thermo ScientificThermo Scientific MTR 21 IVD-MD750025912026-03-10
10850044310484Thermo ScientificThermo Scientific MTR 21 IVD-MD750025992026-03-10
10850044310491Thermo ScientificThermo Scientific MTR 17 IVD-MD750025972026-03-10
10850044310033Thermo ScientificThermo Scientific C1TR IVD-MD750091022025-12-01
10850044310149Thermo ScientificThermo Scientific C1FR IVD-MD750091202025-12-01
10850044310170Thermo ScientificThermo Scientific C1T IVD-MD750080042025-12-01
10850044310187Thermo ScientificThermo Scientific C1T IVD-MD750080052025-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850044310262Thermo ScientificThermo Electron LED GmbHJQC2026-05-21
10850044310279Thermo ScientificThermo Electron LED GmbHJQC2026-05-21
10850044310309Thermo ScientificThermo Electron LED GmbHJQC2026-05-21
00810052864990Boost 2 Flex DC Centrifuge, RevanceDRUCKER DIAGNOSTICSJQC2026-05-11
00810052865003Boost 4 Centrifuge, Pointiva MedicalDRUCKER DIAGNOSTICSJQC2026-05-11
00810052864983DASH Pro 24 Centrifuge, DruckerDRUCKER DIAGNOSTICSJQC2026-05-04
00810052864976TrueBond TriFLEX Centrifuge, PivetalDRUCKER DIAGNOSTICSJQC2026-04-29
10850044310323Fisher ScientificThermo Electron LED GmbHJQC2026-04-22
10850044310347Fisher ScientificThermo Electron LED GmbHJQC2026-04-22
10850044310354Fisher ScientificThermo Electron LED GmbHJQC2026-04-22
10850044310422Fisher ScientificThermo Electron LED GmbHJQC2026-04-22
10850044310224Thermo ScientificThermo Electron LED GmbHJQC2026-04-02
10850044310248Thermo ScientificThermo Electron LED GmbHJQC2026-04-02
00860015460660Nextgen CentrifugeT AESTHETICS LLCJQC2026-04-02
00810052863016DASH Flex 24 Centrifuge, Royal BiologicsDRUCKER DIAGNOSTICSJQC2026-03-25
00810052864969DASH Flex 24 Centrifuge, Royal BiologicsDRUCKER DIAGNOSTICSJQC2026-03-25
00840095681674Globe ScientificGLOBE SCIENTIFIC INC.JQC2026-03-16
10850044310255Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310286Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310293Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310378Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310392Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310484Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310491Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
00664816006030LW Scientific, Inc`LW SCIENTIFIC, INC.JQC2026-03-02
00664816006016LW ScientificLW SCIENTIFIC, INC.JQC2026-02-20
00664816005682LW Scientific, Inc.LW SCIENTIFIC, INC.JQC2026-02-16
00810052864945642M Centrifuge, AccuReferenceDRUCKER DIAGNOSTICSJQC2026-02-02
00810052864938TrueBond Set 3 Centrifuge, ZoetisDRUCKER DIAGNOSTICSJQC2026-01-15
G668FG0020ASCENT FLEXXBMCORTHOASCENT, LLCJQC2026-01-05