Affymetrix

Basic Information

• Brand Name: Affymetrix
• Primary DI: 00856826006043
• Version / Model: 00-0146
• Catalog Number: 00-0146
• Company Name: AFFYMETRIX, INC.
• Labeler DUNS: 804682573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2021-03-25
• Public Version Status: Update
• Public Device Record Key: e10af46b-a799-4201-a89e-647f96c03d70

Device Description

Autoloader w/EBR- GCS3000Dx

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• 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
36225	Scanning laser optical microscope	A microscope designed to obtain high-magnification cross-sectional [three-dimensional (3-D)] images by scanning the sample with the focused point of laser light, restricting the illumination to a tiny, targeted section of the specimen while eliminating out-of-focus light (confocal microscopy). The image data is detected, amplified, and usually digitized and displayed on a high resolution (typically 1024 x 1024 pixel) monitor. The data can be stored, e.g., in a computer. This microscope can be mounted on conventional or specially designed light microscopes, e.g., upright or inverted stage, and is mostly used for cell and molecular biology examinations, e.g., cells, cell cultures or tissue.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856826006043	GS1