FDA.report

CYT7U-SI

Primary DI
05700574034603
Brand
CYT7U-SI
Company
AGILENT TECHNOLOGIES, INC.
Model
CYT7U-SI
Device description
Cell Imaging Multi-Mode Reader
Published
2022-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JJQCOLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE

Product Code Classifications

CodeDeviceSpecialtyClass
JJQColorimeter, Photometer, Spectrophotometer For Clinical UseClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05700574034603PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05700574034603057005740346035700574034603

GMDN Terms

TermDefinition
Cell-imaging microplate reader IVDA mains electricity (AC-powered) laboratory instrument intended to be used for live cell imaging and observation of cell-based assays in microplates, and for the optical detection of analytes in a clinical specimen. The device it typically a single unit consisting of a digital microscope and a multi-modality (i.e., fluorescence, chemiluminescence, absorbance) optical reader. It may also be temperature and gas controlled (i.e., CO2 and O2) for incubation of microplates. The device operates with minimal technician involvement and complete automation of all procedural steps.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1-800-227-9770Global.RA@agilent.com

Regulatory Flags

DUNS number
084963177
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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