FDA.report

Thermo Fisher

Primary DI
05051663001601
Brand
Thermo Fisher
Company
SHANDON DIAGNOSTICS LIMITED
Model
LINISTAT
Device description
SLIDE STAINER 230V 50HZ
Published
2020-09-19
Public version status
Update
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
KPASlide Stainer, Automated

Product Code Classifications

CodeDeviceSpecialtyClass
KPASlide Stainer, AutomatedPathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05051663001601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05051663001601050516630016015051663001601

GMDN Terms

TermDefinition
Microscope slide stainer IVDAn automated mains electricity (AC-powered) laboratory instrument intended to be used to stain blood, tissue and/or other clinical specimens fixed to microscope examination slides, using one or more biological or cytochemical staining solutions in preparation for subsequent microscopic analysis. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods

Method

Regulatory Flags

DUNS number
219103512
Device count
1
DM exempt
false
Premarket exempt
true
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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