FDA.reportPublic FDA data

SureScan Dx Microarray Scanner

Primary DI
05700571108703
Brand
SureScan Dx Microarray Scanner
Company
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
Model
G5761A
Device description
SureScan Dx Microarray Scanner
Published
2017-11-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NSUInstrumentation for clinical multiplex test systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSUInstrumentation For Clinical Multiplex Test SystemsClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700571108703PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700571108703057005711087035700571108703

GMDN Terms#

Term, Definition table
TermDefinition
Microarray analyser IVD, semi-automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the in vitro determination of multiple target analytes in a single clinical specimen using oligonucleotide capture molecules arranged in a consistent pattern on a slide, chip or membrane. Identification of a target sequence in the clinical specimen is by hybridization of complementary base pairs, with a detection system typically using fluorophores, fluorescent-labelled dyes, and/or digital imaging techniques. The device operates with reduced technician involvement and automation of some, but not 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
+1-800-227-9770Global.RA@agilent.com

Regulatory Flags#

DUNS number
894671143
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

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05700572005841Mono Mo A-Hu CD35 Cl Ber-MAC-DRCM08462020-09-17
05700572004912Mono Mo A-Vimentin Cl V9M07252020-09-17
05700572027942Mono Mo A-Vimentin Cl V9M07252020-09-17
05700572516170Mono Mo A-Epstein-Barr Virus, LMP Cls CS. 1-4M08972020-09-17
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