FDA.report

COULTER EPICS

Primary DI
15099590566890
Brand
COULTER EPICS
Company
Beckman Coulter, Inc.
Model
XL 4CL MM120
Catalog number
6605464
Device description
COULTER EPICS XL Flow Cytometer
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GKZCounter, Differential Cell

Product Code Classifications

CodeDeviceSpecialtyClass
GKZCounter, Differential CellHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15099590566890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1509959056689015099590566890

GMDN Terms

TermDefinition
Flow cytometry analyser IVD, semi-automatedA mains electricity (AC-powered) laboratory instrument intended to be used to count, examine and/or sort cells or microscopic particles in a clinical specimen (e.g., blood, urine). Detection of individual components is performed using an optical or electrical detection system based on physical or chemical characteristics, or by detecting immunological markers introduced to the sample during the preanalytical phase and bound via antigen-antibody reactions. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008254708
Device count
1
DM exempt
false
Premarket exempt
false
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

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