LEICA BIOSYSTEMS NEWCASTLE LTD

Address:BALLIOL BUSINESS PARK WEST,NEWCASTLE UPON TYNE,GB

Want to know more about this Organization? Request more information now!

Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Immunohistochemistry Reagents And Kits (NJT) (9) System, Test, Her-2/Neu, Ihc (MVC) (1)

Premarket Exempt

No Yes

Clear

Novocastra™ - 05055331300034 Catalog Number : NCL-L-ZAP-70

Device Description : NCL-L-ZAP-70 is intended for the qualitative identification by light microscopy NCL-L-ZAP-70 is intended for the qualitative identification by light microscopy of ZAP-70 molecules in paraffin sections.

Device Class : 1

Duns Number: 397134693

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : Yes

Device Count : 1

Novocastra™ - 05055331300096 Catalog Number : NCL-L-WT1-562

Device Description : NCL-L-WT1-562 is intended for the qualitative identification by light microscopy NCL-L-WT1-562 is intended for the qualitative identification by light microscopy of human Wilms’ Tumor WT1 gene product in paraffinsections.

Device Class : 1

Duns Number: 397134693

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : Yes

Device Count : 1

Novocastra™ - 05055331300294 Catalog Number : NCL-L-VIM-V9

Device Description : NCL-L-VIM-V9 is intended for the qualitative identification by light microscopy NCL-L-VIM-V9 is intended for the qualitative identification by light microscopy of human vimentin intermediate filament protein in paraffin sections.

Device Class : 1

Duns Number: 397134693

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : Yes

Device Count : 1

Novocastra™ - 05055331300362 Catalog Number : NCL-L-VIM-572

Device Description : NCL-L-VIM-572 is intended for the qualitative identification by light microscopy NCL-L-VIM-572 is intended for the qualitative identification by light microscopy of Vimentin molecules in paraffin sections.

Device Class : 1

Duns Number: 397134693

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : Yes

Device Count : 1

Novocastra™ - 05055331300584 Catalog Number : NCL-L-TYROS

Device Description : NCL-L-TYROS is intended for the qualitative identification by light microscopy o NCL-L-TYROS is intended for the qualitative identification by light microscopy of Tyrosinase molecules in paraffin sections.

Device Class : 1

Duns Number: 397134693

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : Yes

Device Count : 1

Novocastra™ - 05055331300676 Catalog Number : NCL-L-TTF-1

Device Description : NCL-L-TTF-1 is intended for the qualitative identification by light microscopy o NCL-L-TTF-1 is intended for the qualitative identification by light microscopy of Thyroid Transcription Factor-1 in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist

Device Class : 1

Duns Number: 397134693

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : Yes

Device Count : 1

Novocastra™ - 05055331300935 Catalog Number : NCL-L-TPO

Device Description : NCL-L-TPO is intended for the qualitative identification by light microscopy of NCL-L-TPO is intended for the qualitative identification by light microscopy of Thyroid Peroxidase molecules in paraffin sections.

Device Class : 1

Duns Number: 397134693

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : Yes

Device Count : 1

Novocastra™ - 05055331301208 Catalog Number : NCL-L-TdT-339

Device Description : NCL-L-TdT-339 is intended for the qualitative identification by light microscopy NCL-L-TdT-339 is intended for the qualitative identification by light microscopy of human terminal deoxynucleotidyl transferase in paraffin sections.

Device Class : 1

Duns Number: 397134693

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : Yes

Device Count : 1

BOND ORACLE HER2 IHC System - 05055331301291 Catalog Number : TA9145

Device Description : Bond Oracle HER2 IHC System is a semi quantitative immunohistochemical assay to Bond Oracle HER2 IHC System is a semi quantitative immunohistochemical assay to determine HER2 oncoprotein status in breast cancer in breast tissue processed for histological evaluation.

Device Class : 3

Duns Number: 397134693

Premarket Exempt : No

Product Code : MVC

Prescription Use : No

Device Count : 1

Novocastra™ - 05055331301352 Catalog Number : NCL-L-SYNAP-299

Device Description : NCL-L-SYNAP-299 is intended for the qualitative identification by light microsco NCL-L-SYNAP-299 is intended for the qualitative identification by light microscopy of Synaptophysin molecules in paraffin sections.

Device Class : 1

Duns Number: 397134693

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : Yes

Device Count : 1

Previous 1 2 3 4 5 … 38 Next