FDA.reportPublic FDA data

Verigene® Reader (Refurbished)

Primary DI
00840487101476
Brand
Verigene® Reader (Refurbished)
Company
LUMINEX CORPORATION
Model
10-0000-02R
Catalog number
10-0000-02R
Device description
The Verigene® Reader is the central control of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications. (Refurbished)
Published
2019-12-05
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
OOIreal time Nucleic acid amplification system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSUInstrumentation For Clinical Multiplex Test SystemsClinical Chemistry2
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857573006393PreviousGS10
00840487101476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857573006393008575730063938575730063930857573006393
00840487101476008404871014768404871014760840487101476

GMDN Terms#

Term, Definition table
TermDefinition
Multiplex analyser IVD, laboratoryAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative simultaneous determination of multiple chemical and/or biological markers in a single clinical specimen using an immunological method which incorporates multiple antibodies arranged on a solid surface (e.g., slide, plate, membrane) or coated to micro-particles. It typically includes a system for the detection of bound target antigen (e.g., chemiluminescent, fluorescent, photometric, magnetic detector), together with sample processing, data processing and data display software.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(877)785-2323support@luminexcorp.com

Regulatory Flags#

DUNS number
080778937
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00840487101513Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge20-006-00120-006-0012019-12-05
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00840487101858LIAISON PLEX Gram-Positive Blood Culture Assay20-005-30520-005-3052025-07-11
00840487101865LIAISON PLEX Yeast Blood Culture Assay Kit20-005-30620-005-3062024-10-22
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00840487101841LIAISON PLEX Gram-Negative Blood Culture Assay20-005-30320-005-3032025-06-11
00840487100127MHV Control Primers 5380638062016-12-16
00840487100233MultiCode® Chlamydophila pneumoniae Primers392539252016-12-16
00840487100240MultiCode® Legionella pneumophila Primers392639262016-12-16
00840487100257MultiCode® Mycoplasma pneumoniae Primers392739272016-12-16
00840487101049MHV DNA Sample Processing Control370037002016-12-16
00840487101056MHV DNA Sample Processing Control3700-023700-022016-12-16
00840487101063MHV DNA Sample Processing Control3700-213700-212016-12-16
00840487101070MHV DNA Sample Processing Control3700-223700-222016-12-16
00840487101087MHV DNA Sample Processing Control371037102016-12-16
00840487101100MHV DNA Amplification Control369436942016-12-16
00840487101155MHV Control Primers 1380238022016-12-16
00840487101179MHV Control Primers 2380338032016-12-16
00840487101186MHV Control Primers 23803-213803-212016-12-16
00840487101193MHV Control Primers 3380438042016-12-16

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