FDA.reportPublic FDA data

binx io

Primary DI
05060441760005
Brand
binx io
Company
BINX HEALTH LIMITED
Model
V1
Catalog number
3.001.001
Device description
binx io instrument
Published
2025-09-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200533000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200533000binx io CT/NG Assay and binx io CT/NG SystemBinx Health, Inc.2020-04-27QEP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060441760005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060441760005050604417600055060441760005

GMDN Terms#

Term, Definition table
TermDefinition
Thermal cycler nucleic acid amplification analyser IVD, point-of-careA portable, electrically-powered instrument intended to be used by healthcare professionals at the point-of-care to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or quantified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
347089851
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060441760036binx ioV1 (CT/NG)5.002.0012025-09-03
05060441760043binx ioV1 (CT/NG)5.012.0012025-09-03
05060441760050binx ioV1 (CT/NG)1.002.1012025-09-03
15060441760033binx ioV1 (CT/NG)5.002.0012025-09-03
15060441760040binx ioV1 (CT/NG)5.012.0012025-09-03
25060441760054binx ioV1 (CT/NG)1.002.1012025-09-03

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Primary DI, Brand, Company table
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10190302019903Applied BioSystems™ JUN™ Dye Spectral Calibration Plate for Multiplex qPCR, FastLIFE TECHNOLOGIES HOLDINGS PTE. LTD.NSU2025-08-19
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00840487101971LIAISON PLEX® ModuleLUMINEX CORPORATIONNSU2024-06-20
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