FDA.reportPublic FDA data

Titan Prime Universal HRP Polymer Detection Kit with DAB

Primary DI
00850042030097
Brand
Titan Prime Universal HRP Polymer Detection Kit with DAB
Company
Lumatas Biosystems, Inc.
Model
1
Device description
A Detection System Kit containing four components. Polymer based detection system used in conjunction with DAB chromogen to allow for visualization of the tissue sample.
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
00850042030097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850042030097008500420300978500420300970850042030097

GMDN Terms#

Term, Definition table
TermDefinition
Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistryA collection of reagents and other associated materials intended to be used for the discrete visualisation of immune complexes bound to specific cellular markers in a clinical specimen. Sustrates are used to detect immunoperoxidase-bound complexes and may include diaminobenzidine (DAB), aminoethylcarbazole (AEC), nitro blue tetrazolium/bromochloroindolyl phosphate (NBT/BCIP) and/or fast red using an enzyme immunohistochemistry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 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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