FDA.reportPublic FDA data

Q-STAIN® X Autostainer

Primary DI
00850036867159
Brand
Q-STAIN® X Autostainer
Company
NOVODIAX, INC.
Model
IA01-001
Catalog number
IA01-001
Device description
Q-STAIN X Autostainer
Published
2022-02-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00850036867159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850036867159008500368671598500368671590850036867159

GMDN Terms#

Term, Definition table
TermDefinition
Microscope slide maker/stainer IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used to prepare, transfer or fix blood, tissue or other clinical specimens onto microscope examination slides, and then stain the slides using one or more biological or cytochemical staining solutions in preparation for subsequent microscopic analysis. The device operates with minimal technician involvement and complete automation of all procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5103423043support@novodiax.com

Regulatory Flags#

DUNS number
965326957
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850041202419QSX-Enh-P HER2 (ASR)AP31063-004AP31063-0042023-03-20
00850036867753Q-STAIN® QSX-Enh-P WT-1QP32045-004QP32045-0042023-11-21
00850036867760Q-STAIN® QSX-Enh-F WT-1QF32045-004QF32045-0042023-11-21
00850036867777Q-STAIN® QSX-Enh-P Gal-3QP32025-004QP32025-0042023-11-21
00850036867784Q-STAIN® QSX-Enh-F Gal-3QF32025-004QF32025-0042023-11-21
00850036867791Q-STAIN® QSX-Enh-P TROP2QP32044-004QP32044-0042023-11-21
00850036867807Q-STAIN® QSX-Enh-F TROP2QF32044-004QF32044-0042023-11-21
00850041202365Q-STAIN® QSX-Enh-F CgAQF32035-004QF32035-0042023-11-21
00850041202372Q-STAIN® QSX-Enh-P CgAQP32035-004QP32035-0042023-11-21
00850036867449Q-STAIN® QSX-Enh-F CD34QF31046-004QF31046-0042023-03-20
00850036867555Q-STAIN® QSX-Enh-P CD34QP31046-004QP31046-0042023-03-20
00850041202389ihc CD34 Ab (3mL)KF31046-003F31046-R003 / KF31046-0032023-03-20
00850041202396ihc CD34 Ab (5mL)KF31046-005F31046-R005 / KF31046-0052023-03-20
00850041202426QSX-Enh-P ER (ASR)AP32052-004AP32052-0042023-03-20
00850041202433QSX-Enh-P PR (ASR)AP32053-004AP32053-0042023-03-20
00850036867166Q-STAIN® QSX-Enh-P GFAP QP32002-004QP32002-0042022-07-21
00850036867173Q-STAIN® QSX-Enh-P CD20 QP32029-004QP32029-0042022-07-21
00850036867180Q-STAIN® QSX-Enh-P VimentinQP32021-004QP32021-0042022-07-21
00850036867234Q-STAIN® QSX-Enh-F Ki67 QF32001-004QF32001-0042022-07-21
00850036867258Q-STAIN® QSX-Enh-F SYN QF32034-004QF32034-0042022-07-21

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
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
05700571112311DakoAGILENT TECHNOLOGIES, INC.KPA2024-08-07