FDA.reportPublic FDA data

intelliPATH FLX Automated Slide Staining System

Primary DI
00847627031716
Brand
intelliPATH FLX Automated Slide Staining System
Company
BIOCARE MEDICAL LLC
Model
IPS0001US
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00847627031716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847627031716008476270317168476270317160847627031716

GMDN Terms#

Term, Definition table
TermDefinition
Microscope slide maker/digital imaging analyser IVDAn electronic benchtop device intended to be used in a histopathology laboratory for: 1) the automated preparation and staining of a clinical specimen (e.g., whole blood) on a microscope examination slide or slide-like cartridge; 2) microscopy digital scanning/imaging; and 3) software-assisted analysis/interpretation of the acquired images. It consists of an integrated unit with built-in motorized specimen preparation stage, digital microscope, user interface, and clinical application-specific artificial intelligence (AI)/deep learning software. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806617825
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
00847627043726NeoPath Background Punisher NPRI10029T402026-03-11
00847627042637Pan TRK [RM423]NPAI3267T402026-02-19
00847627042279CK7NPAI339T402026-01-29
00847627043023NeoPATH Pro Rabbit Amp AP Plus KitNPRI10097KT135 2026-01-29
00847627043047NeoPATH Pro Universal AP Plus Polymer KitNPRI10101KT1352026-01-29
00847627043061NeoPATH Pro Antigen Retrieval 1 (AR1)NPRI10106T50 2026-01-29
00847627042033DesminNPAI036T402026-01-13
00847627042835CD19NPAI310T402026-01-13
00847627041937Myeloperoxidase (P)NPAI023T402026-01-06
00847627042514VimentinNPAI048T402026-01-06
00847627041999HER2/neu [IHC042]NPAA3274T402025-12-16
00847627042019CD43NPAI005T402025-12-16
00847627042118Cytokeratin 18 (CK18)NPAI3061T402025-12-16
00847627042491CD79aNPAI067T402025-12-16
00847627042576Cytokeratin [AE1] LMWNPAI081T402025-12-16
00847627042897CD103 (RM)NPAI3117T402025-12-16
00847627042071Mammaglobin (M)NPAI269T402025-11-25
00847627042132CD7NPAI158T402025-11-25
00847627042965Pan Melanoma Cocktail-2PM178H2025-11-17
00847627039095Desmoglein 3NPAI419T402025-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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
08435804518970VitroStainer 42VITRO 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
05700571112342DakoAGILENT TECHNOLOGIES, INC.KPA2024-08-07
05700571112311DakoAGILENT TECHNOLOGIES, INC.KPA2024-08-07
05700571112328DakoAGILENT TECHNOLOGIES, INC.KPA2024-08-07
09349458005634BONDLEICA BIOSYSTEMS MELBOURNE PTY LTDKPA2024-08-02
09349458005641BONDLEICA BIOSYSTEMS MELBOURNE PTY LTDKPA2024-08-02
09349458005658BONDLEICA BIOSYSTEMS MELBOURNE PTY LTDKPA2024-08-02