AccessGUDID - DEVICE: Novocastra™ (05055331301970)

GUDID

Device Identifier (DI) Information

Brand Name: Novocastra™
Version or Model: RE7160-CE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RE7160-K
Company Name: LEICA BIOSYSTEMS NEWCASTLE LTD

Primary DI Number: 05055331301970
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 397134693 *Terms of Use

Device Description: NovocastraTM Enzyme Proteinase K (IHC) is intended for the enzymatic pretreatment of formalin-fixed, paraffin-embedded tissue sections prior to incubation with a primary antibody in an immunohistochemical (IHC) procedure.

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?
57778	Immunohistochemistry protease reagent IVD	A substance or reactant which may include proteinase K and/or pepsin intended to be used for the enzymatic retrieval of antigenic epitopes from tissue in an enzyme immunohistochemistry assay performed on biological tissues or clinical specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PPM	General Purpose Reagent

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: 37b579c8-57c4-4e35-81d8-9b5b8d15c332
Public Version Date: March 29, 2021
Public Version Number: 1
DI Record Publish Date: March 19, 2021