FDA.reportPublic FDA data

LLXW-SI

Primary DI
05700574037307
Brand
LLXW-SI
Company
AGILENT TECHNOLOGIES, INC.
Model
LLXW-SI
Device description
Automated Microscope
Published
2022-05-01
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
IBKMICROSCOPE, FLUORESCENCE/U.V.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IBKMicroscope, Fluorescence/U.V.Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700574037307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700574037307057005740373075700574037307

GMDN Terms#

Term, Definition table
TermDefinition
Cell morphology analyser IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used to capture digital images of a clinical specimen at the microscopic level in order to view, count, record and evaluate the morphological characteristics of the cells and other biological components. It is a computerized optical unit consisting of a microscope, camera and software. The device operates with minimal technician involvement and complete automation of all procedural steps.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-877-424-4536contact_us@agilent.com

Regulatory Flags#

DUNS number
084963177
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
05700575016899PD-L1 Control SlidesT13912026-04-29
05700573001736PD-L1 Control SlidesT13912020-11-17
05700575018107Monoclonal Mouse Anti-Human Integrin Beta-6, Clone 6.2A1M36752026-01-21
05700571102305Mono Mo A-Hu Progesterone Receptor, Cl PgR 636M35692016-09-16
05700571107713DakoGC2062024-08-07
05700575005213MLH1 IHC pharmDx (Dako Omnis)GE0792025-08-27
05700575005220MSH2 IHC pharmDx (Dako Omnis)GE0852025-08-27
05700575005237MSH6 IHC pharmDx (Dako Omnis)GE0862025-08-27
05700575005244PMS2 IHC pharmDx (Dako Omnis)GE0872025-08-27
05700575005251MMR Negative Control Reagent, Mouse (Dako Omnis)GE1012025-08-27
05700575005268MMR Negative Control Reagent, Rabbit (Dako Omnis)GE1022025-08-27
05700571102022Mono Mo A-Adrenocorticotropin (ACTH) Cl 02A3M35012020-09-17
05700571102053Mono Mo A-Hu Follicle Stimulating Hormone (FSH) Cl C10M35042020-09-17
05700571102190Mono Mo A-Hu Beta-Catenin Cl ß-Catenin-1M35392020-09-17
05700571102503Mono Mo A-Hu Tyrosinase Cl T311M36232020-09-17
05700571101933Mono Mo A-Thrombomodulin Cl 1009M06172020-09-17
05700571102039Mono Mo A-Hu Luteinizing Hormone (LH) Cl C93M35022020-09-17
05700571101995Mono Mo A-Hu Muscle Actin Cl HHF35M06352020-09-17
05700571105146Mono Mo A-Hu Progesterone Receptor, Cl PgR 1294M35682016-09-16
05700571102046Mono Mo A-Hu Thyroid Stimulating Hormone (TSH) Cl 0042M35032020-09-17

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Primary DI, Brand, Company table
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00664816001967LW Scientific, Inc.LW SCIENTIFIC, INC.IBK2023-06-27
00664816002261LW Scientific, Inc.LW SCIENTIFIC, INC.IBK2023-06-27
00664816002278LW Scientific, Inc.LW SCIENTIFIC, INC.IBK2023-06-27
00664816002285LW Scientific, Inc.LW SCIENTIFIC, INC.IBK2023-06-27
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08602920003035VivaScope 2500Caliber Imaging & Diagnostics, Inc.IBK2023-02-16
04049016147787EUROPattern Microscope LiveEUROIMMUN Medizinische Labordiagnostika AGIBK2022-12-08
05700574035099LFX-SIAGILENT TECHNOLOGIES, INC.IBK2022-05-01
05700574035105LLX-SIAGILENT TECHNOLOGIES, INC.IBK2022-05-01
05700574037062LFXBIOAGILENT TECHNOLOGIES, INC.IBK2022-05-01
05700574037291LFXW-SIAGILENT TECHNOLOGIES, INC.IBK2022-05-01