FDA.reportPublic FDA data

Exicycler™ 384

Primary DI
08809537070751
Brand
Exicycler™ 384
Company
Bioneer Corporation
Model
A-2061
Catalog number
A-2061
Published
2021-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OOIReal Time Nucleic Acid Amplification System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809537070751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809537070751088095370707518809537070751

GMDN Terms#

Term, Definition table
TermDefinition
Thermal cycler nucleic acid amplification analyser IVD, laboratory, 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 and/or culture isolate prior to amplification, and operates with minimal technician input and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688014216
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809537078412Exicycler™ V5 96A-2065-12024-09-09
08809537078429Exicycler™ V5 96 FastA-2065-22024-09-09
08809537078436Exicycler™ V5 384A-2065-32024-09-09
08809537078443Exicycler™ V5 384 FastA-2065-42024-09-09
08809537070034Exicycler™ 96A-2060-1A-2060-12021-07-22
08809537070058ExiPrep™48 DxA-51502022-09-02
08809537070065ExiPrep™16 DxA-50502022-09-02
08809537070188ExiPrep™96 LiteA-52502022-09-02
08809537077750ExiPrep™16 PlusA-50302022-09-02
08809357174134ExiPrep™ Dx Viral RNA KitK-4473K-44732022-09-02
08809357174158ExiPrep™ Dx Viral DNA/RNA KitK-4471K-44712022-09-02
08809357174172ExiPrep™ Dx Viral DNA KitK-4472K-44722022-09-02
08809357174196ExiPrep™ Dx Blood Genomic DNA KitK-4411K-44112022-09-02
08809357174219ExiPrep™ Dx Bacteria Genomic DNA KitK-4414K-44142022-09-02
08809357174233ExiPrep™ Dx Mycobacteria Genomic DNA KitK-4418K-44182022-09-02
08809357178309ExiPrep™ 48 Viral DNA/RNA KitK-4571K-45712022-09-02
08809357178316ExiPrep™ 48 Viral RNA KitK-4573K-45732022-09-02
08809357179481ExiPrep™ 96 Viral DNA/RNA KitK-4614K-46142022-09-02
08809357179498MagListo™ 5M Viral DNA/RNA Extraction KitK-3617K-36172022-09-02
08809357179870ExiPrep™ 96 Genomic DNA KitK-4611K-46112022-09-02

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