FDA.reportPublic FDA data

DAB Away Kit

Primary DI
00850042030165
Brand
DAB Away Kit
Company
Lumatas Biosystems, Inc.
Model
1
Device description
A cleaning kit containing three components. Used for the removal of DAB from Automated Tissue Staining Instrument.
Published
2023-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NJTImmunohistochemistry Reagents And Kits

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850042030165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850042030165008500420301658500420301650850042030165

GMDN Terms#

Term, Definition table
TermDefinition
Wash/cleaning solution IVD, automated/semi-automated systemA concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080169635
Device count
1
Premarket exempt
true
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810202560406goldFISHDF0102025-11-18
00810202560413goldFISHDF0112025-11-18
00810202560420goldFISHDF0122025-11-18
00810202560437goldFISHDF0222025-11-18
00810202560444goldFISHDF0232025-11-18
00810202560451goldFISHDF0242025-11-18
00810202560468goldFISHDF0282025-11-18
00810202560475goldFISHDF0292025-11-18
00810202560482goldFISHDF0302025-11-18
00810202560499goldFISHDF0312025-11-18
00810202560505goldFISHDF0322025-11-18
00810202560512goldFISHDF0332025-11-18
00810202560529goldFISHDF0482025-11-18
00810202560536goldFISHDF0492025-11-18
00810202560543goldFISHDF0522025-11-18
00810202560550goldFISHDF0532025-11-18
00810202560567goldFISHDF0542025-11-18
00810202560574goldFISHDF0562025-11-18
00810202560581goldFISHDF0612025-11-18
00810202560598goldFISHDF0632025-11-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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