FDA.report

DxH Slidemaker Stainer II

Primary DI
15099590701567
Brand
DxH Slidemaker Stainer II
Company
Beckman Coulter, Inc.
Model
C11477
Device description
UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System
Published
2018-05-03
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

Related Records

Product Codes

CodeName
GKZCounter, Differential Cell
KPASlide Stainer, Automated

Product Code Classifications

CodeDeviceSpecialtyClass
GKZCounter, Differential CellHematology2
KPASlide Stainer, AutomatedPathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15099590701567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1509959070156715099590701567

GMDN Terms

TermDefinition
Specimen processing instrument IVD, automatedA mains electricity (AC-powered) instrument or platform intended to be used for the automated pre-analytical preparation of a clinical specimen (excluding specimens for microbial culture), which may include the sampling, diluting, and/or aliquoting of clinical specimens and/or any post-analytical processing required, including labelling, storage and/or location data. The device operates with minimal technician involvement and automation of 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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