Applied BioSystems™ ABY™ Dye Spectral Calibration Plate for Multiplex qPCR, Fast

Basic Information

• Brand Name: Applied BioSystems™ ABY™ Dye Spectral Calibration Plate for Multiplex qPCR, Fast
• Primary DI: 10190302019897
• Version / Model: A65487
• Company Name: LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
• Labeler DUNS: 628548377
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-19
• Public Version: 1
• Public Version Date: 2025-08-27
• Public Version Status: New
• Public Device Record Key: a836c347-17ae-427c-9c5e-cc040d099aea

Device Description

Applied Biosystems ABY Dye Spectral Calibration Plate for Multiplex qPCR used for ABY dye spectral calibration of the Applied Biosystems 7500 Fast Dx Real Time PCR Instrument.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	862.2570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61303	Thermal cycler nucleic acid instrument calibrator/control kit IVD	A collection of reagents and other associated materials of known characteristics intended to be used to calibrate or verify the performance of a thermal cycler nucleic acid instrument/analyser [e.g., real-time polymerase chain reaction (PCR) machine] to ensure its proper function prior to analysis/processing of clinical samples.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10190302019897	GS1