HistoCore SPECTRA ST 14051254354

GUDID 04049188191953

The HistoCore SPECTRA ST is an in-vitro diagnostics instrument. The HistoCore SPECTRA ST is a stainer for laboratory applications and intended for the

Leica Biosystems Nussloch GmbH

Microscope slide stainer IVD
Primary Device ID04049188191953
NIH Device Record Key03b7e5e6-c5a7-4de2-bdef-504a960d50d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameHistoCore SPECTRA ST
Version Model Number000000014051254354
Catalog Number14051254354
Company DUNS315539452
Company NameLeica Biosystems Nussloch GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+4962241430
EmailCHS.support@LeicaBiosystems.co

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *

Device Identifiers

Device Issuing AgencyDevice ID
GS104049188191953 [Primary]

FDA Product Code

KPASlide stainer, automated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-17
Device Publish Date2018-11-16

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