FDA.reportPublic FDA data

Diagnostic BioSystems

Primary DI
00846405013999
Brand
Diagnostic BioSystems
Company
Diagnostic Biosystems, Inc.
Model
AR365
Device description
Montage Opus 365 System ,1 ea
Published
2026-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KPASlide Stainer, Automated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPASlide Stainer, AutomatedPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846405013999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846405013999008464050139998464050139990846405013999

GMDN Terms#

Term, Definition table
TermDefinition
Pressurized incubator IVDAn electrically-powered pressurized heating chamber intended to be used for the incubation of laboratory specimens for subsequent in vitro diagnostic procedures [e.g., heat-induced epitope retrieval (HIER) and deparaffinization for immunohistochemistry]. It is typically in the form of a pot, similar to a pressure cooker, with a lid and a removable inner liner, where samples are placed in a holder or tray for heating. It is programmable with dedicated software to control settings for temperature, pressure, and incubation time.

Regulatory Flags#

DUNS number
926549064
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846405000036Diagnostic BioSystemsMob429-012026-06-08
00846405000227Diagnostic BioSystemsMob125R2026-06-08
00846405000234Diagnostic BioSystemsMob125-05R2026-06-08
00846405000241Diagnostic BioSystemsMob125R-012026-06-08
00846405000319Diagnostic BioSystemsMob4602026-06-08
00846405000326Diagnostic BioSystemsMob460-052026-06-08
00846405000333Diagnostic BioSystemsMob460-012026-06-08
00846405000371Diagnostic BioSystemsMob1172026-06-08
00846405000388Diagnostic BioSystemsMob117-052026-06-08
00846405000395Diagnostic BioSystemsMob117-012026-06-08
00846405000463Diagnostic BioSystemsMob2942026-06-08
00846405000470Diagnostic BioSystemsMob294-052026-06-08
00846405000487Diagnostic BioSystemsMob294-012026-06-08
00846405000524Diagnostic BioSystemsMob0282026-06-08
00846405000531Diagnostic BioSystemsMob028-052026-06-08
00846405000548Diagnostic BioSystemsMob028-012026-06-08
00846405000616Diagnostic BioSystemsMob3322026-06-08
00846405000623Diagnostic BioSystemsMob332-052026-06-08
00846405000630Diagnostic BioSystemsMob332-012026-06-08
00846405000913Diagnostic BioSystemsMob3092026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846405019281Diagnostic BioSystemsDiagnostic Biosystems, Inc.KPA2026-06-05
00630414289700Atellica HEMA Slidemaker Stainer (SMS)Siemens Healthcare Diagnostics Inc.KPA2026-02-06
00380740213572AlinityABBOTT LABORATORIESKPA2025-12-25
04015630984510BenchMark Special Stains Stainer ModuleVentana Medical Systems, Inc.KPA2025-12-15
07613336140956BenchMark GXVentana Medical Systems, Inc.KPA2025-12-15
05700571112182DakoAGILENT TECHNOLOGIES SINGAPORE PTE LTDKPA2025-09-02
05700575000416Dako Omnis 165 DuoAGILENT TECHNOLOGIES SINGAPORE PTE LTDKPA2025-07-01
09349458005672BOND-III Processing ModuleLEICA BIOSYSTEMS MELBOURNE PTY LTDKPA2025-06-30
09349458005689BOND-MAX Processing ModuleLEICA BIOSYSTEMS MELBOURNE PTY LTDKPA2025-06-30
05700575000423Dako Omnis 110AGILENT TECHNOLOGIES SINGAPORE PTE LTDKPA2025-06-25
05700575013812Dako Omnis DI Water Filling AccessoriesAGILENT TECHNOLOGIES SINGAPORE PTE LTDKPA2025-06-25
05700575014017Dako Omnis Clean Liquid System HardwareAGILENT TECHNOLOGIES SINGAPORE PTE LTDKPA2025-06-25
05700575014024Dako Omnis DIW TankAGILENT TECHNOLOGIES SINGAPORE PTE LTDKPA2025-06-25
05700575014031Dako Omnis Waste Tank (NHz)AGILENT TECHNOLOGIES SINGAPORE PTE LTDKPA2025-06-25
05700575014048Dako Omnis Waste Tank (Hz)AGILENT TECHNOLOGIES SINGAPORE PTE LTDKPA2025-06-25
05700575014413Dako Omnis Waste Accessories (Direct)AGILENT TECHNOLOGIES SINGAPORE PTE LTDKPA2025-06-25
05700575014420Dako Omnis Waste Accessories (Indirect)AGILENT TECHNOLOGIES SINGAPORE PTE LTDKPA2025-06-25
05700575000430Dako Omnis 165AGILENT TECHNOLOGIES SINGAPORE PTE LTDKPA2025-06-24
B502BSB74000TintoStainer Plus Automated SystemBIO SB, INC.KPA2025-03-28
B502BSB7400100TintoStainer Plus Automated System MiniBIO SB, INC.KPA2025-03-28
B502BSB7400600TintoStainer Plus Automated System LXBIO SB, INC.KPA2025-03-28
08435421271890VitroStainer 42VITRO SAKPA2025-02-20
08435804518970NeoPATH ProVITRO SAKPA2025-02-20
04065271997561MIDAS® III-Plus Automated StainerSigma-Aldrich, Inc.KPA2025-01-20
06971182571326Fully Automated IHC StainerDakewe (Shenzhen) Medical Equipment Co., Ltd.KPA2024-12-27
09349458005665BOND-PRIME automated stainerLEICA BIOSYSTEMS MELBOURNE PTY LTDKPA2024-10-18
05700571107713DakoAGILENT TECHNOLOGIES, INC.KPA2024-08-07
05700572034551DakoAGILENT TECHNOLOGIES, INC.KPA2024-08-07
05700572034568DakoAGILENT TECHNOLOGIES, INC.KPA2024-08-07
05700571112342DakoAGILENT TECHNOLOGIES, INC.KPA2024-08-07