AccessGUDID - DEVICE: Novocastra™ (05055331325235)

GUDID

Device Identifier (DI) Information

Brand Name: Novocastra™
Version or Model: PLK-1-L-CE
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NCL-L-PLK-1
Company Name: LEICA BIOSYSTEMS NEWCASTLE LTD

Primary DI Number: 05055331325235
Issuing Agency: GS1
Commercial Distribution End Date: November 17, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 397134693 *Terms of Use

Device Description: NCL-L-PLK-1 is intended for the qualitative identification by light microscopy of PLK-1 protein in paraffin sections.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62821	Polo-like kinase-1 (PLK1) IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of polo-like kinase-1 (PLK1), also known as serine/threonine-protein kinase 13 (STPK13), in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NJT	Immunohistochemistry Reagents And Kits

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e7981679-84ee-463a-ab6e-8d327dc9e004
Public Version Date: November 20, 2023
Public Version Number: 2
DI Record Publish Date: December 07, 2022