AccessGUDID - DEVICE: ProtoFluor Reagent System (Part 2 of 2) (M5255510570)

GUDID

Device Identifier (DI) Information

Brand Name: ProtoFluor Reagent System (Part 2 of 2)
Version or Model: 551057
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HELENA LABORATORIES CORPORATION

Primary DI Number: M5255510570
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?
53538	Protoporphyrin IX 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 the qualitative and/or quantitative detection of the porphyrin metabolite protoporphyrin IX in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JKJ	FLUOROMETRIC MEASUREMENT, PORPHYRINS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K893038	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: 95a7f7da-7396-44c3-b719-89edc82e471e
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: March 17, 2017