Lumatas Automated Slide Stainer

GUDID 00850042030004

This Automated Slide Stainer is to automate tissue staining procedures used in immunohistochemistry such as the application of immuno-reagents (antibodies) to tissue sections.

Lumatas Biosystems, Inc.

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Primary Device ID00850042030004
NIH Device Record Keybd15ae0c-b633-43db-86e0-fd626e72b9af
Commercial Distribution StatusIn Commercial Distribution
Brand NameLumatas Automated Slide Stainer
Version Model NumberTitan
Company DUNS080169635
Company NameLumatas Biosystems, Inc.
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 25 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850042030004 [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 Date2023-11-02
Device Publish Date2023-10-25

On-Brand Devices [Lumatas Automated Slide Stainer]

00850042030011This Automated Slide Stainer is to automate tissue staining procedures used in immunohistochemis
00850042030004This Automated Slide Stainer is to automate tissue staining procedures used in immunohistochemis

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