AccessGUDID - DEVICE: FREND (08809317540825)

GUDID

Device Identifier (DI) Information

Brand Name: FREND
Version or Model: FREND Blocking Reagent
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FRBR 015
Company Name: NanoEnTek, Inc.

Primary DI Number: 08809317540825
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687910463 *Terms of Use

Device Description: FREND™ Blocking Reagent is provided in 15 tubes, the blocking reagent is buffer based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The Blocking Reagent is provided in a dried solid state.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
57775	Immunohistochemistry endogenous protein blocking reagent IVD	A substance or reactant intended to be used for the blocking of endogenous protein reactivity in an 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: aa32fa8c-2302-4ebe-81e9-564929157681
Public Version Date: November 04, 2020
Public Version Number: 2
DI Record Publish Date: March 24, 2020