AccessGUDID - DEVICE: Amido Black Protein Stain (powder) (M52530480)

GUDID

Device Identifier (DI) Information

Brand Name: Amido Black Protein Stain (powder)
Version or Model: 3048
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HELENA LABORATORIES CORPORATION

Primary DI Number: M52530480
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079396131 *Terms of Use

Device Description: No description.

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:	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?
53970	Protein electrophoresis IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for determining the qualitative and/or quantitative separation of proteins by electrophoresis, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CEF	ELECTROPHORETIC, PROTEIN FRACTIONATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K972274	000

Device Exempt from Premarket Submission: No 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: a3ab87f6-b38b-4821-924e-90ee4c8b7d83
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: March 17, 2017