FDA.reportPublic FDA data

Azure Cielo Dx

Primary DI
00860006465612
Brand
Azure Cielo Dx
Company
Azure Biosystems Inc.
Model
Azure Cielo 6 Dx
Published
2021-03-17
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

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
00860006465612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860006465612008600064656128600064656120860006465612

GMDN Terms#

Term, Definition table
TermDefinition
Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automatedAn electrically-powered laboratory instrument intended 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 identified 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 prior to amplification, and generally operates with reduced technician involvement and automation of some, but not all procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
032828687
Device count
1
DM exempt
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860006465605Azure Cielo DxAzure Cielo 3 Dx2021-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049016126034EUROArrayScanEUROIMMUN Medizinische Labordiagnostika AGNSU2025-12-19
00851458005327SPOTFIRE Control Station - ITARBIOFIRE DEFENSE, LLCNSU2025-12-16
00851458005334SPOTFIRE Control Station - non-ITARBIOFIRE DEFENSE, LLCNSU2025-12-16
05060441760005binx ioBINX HEALTH LIMITEDNSU2025-09-03
10190302019897Applied BioSystems™ ABY™ Dye Spectral Calibration Plate for Multiplex qPCR, FastLIFE TECHNOLOGIES HOLDINGS PTE. LTD.NSU2025-08-19
10190302019903Applied BioSystems™ JUN™ Dye Spectral Calibration Plate for Multiplex qPCR, FastLIFE TECHNOLOGIES HOLDINGS PTE. LTD.NSU2025-08-19
00840487101858LIAISON PLEX Gram-Positive Blood Culture AssayLUMINEX CORPORATIONNSU2025-07-11
08033891322670CHORUS EVODIESSE DIAGNOSTICA SENESE SPANSU2025-07-01
00840487101841LIAISON PLEX Gram-Negative Blood Culture AssayLUMINEX CORPORATIONNSU2025-06-11
04719880531103QLociLIFEOS GENOMICS CORPORATIONNSU2025-04-30
00850063063005DASH® Rapid PCR InstrumentNuclein, LLCNSU2025-01-06
00856826006203Applied BiosystemsAFFYMETRIX, INC.NSU2024-12-24
15420045517066Aptima®Hologic, Inc.NSU2024-12-19
15420045517073Aptima®Hologic, Inc.NSU2024-12-19
06974849369403EudemonTM AIO800Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.NSU2024-11-14
00815381020727BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel MiniBIOFIRE DIAGNOSTICS, LLCNSU2024-07-26
00840487101957LIAISON PLEX® ChassisLUMINEX CORPORATIONNSU2024-06-20
00840487101964LIAISON PLEX® Chassis (Refurbished)LUMINEX CORPORATIONNSU2024-06-20
00840487101971LIAISON PLEX® ModuleLUMINEX CORPORATIONNSU2024-06-20
00840487101988LIAISON PLEX® Module (Refurbished)LUMINEX CORPORATIONNSU2024-06-20
00875197006926cobas Buffer Negative Control KitRoche Diagnostics GmbHNSU2024-06-05
00382904439767BD Vaginal Panel on BD COR SystemBECTON, DICKINSON AND COMPANYNSU2024-04-02
00851458005297FILMARRAY® COMMERCIAL LAPTOPBIOFIRE DEFENSE, LLCNSU2024-03-19
00195126000871Aptiva® System Cleaning Solution KitINOVA DIAGNOSTICS, INC.NSU2024-03-18
00195126000741Aptiva® Instrument System CuvettesINOVA DIAGNOSTICS, INC.NSU2024-03-11
08426951307227Aptiva® Multi-Analyte InstrumentINOVA DIAGNOSTICS, INC.NSU2024-03-11
08430793041126Aptiva® Optical Calibrator KitINOVA DIAGNOSTICS, INC.NSU2024-03-11
08430793041133Aptiva® Optical Controls KitINOVA DIAGNOSTICS, INC.NSU2024-03-11
08430793041140Aptiva® Optical Cleaning SolutionINOVA DIAGNOSTICS, INC.NSU2024-03-11
08430793041157Aptiva® System RinseINOVA DIAGNOSTICS, INC.NSU2024-03-11