AccessGUDID - DEVICE: Thermo Scientific Protocol™ Parasitology System (00845275005011)

GUDID

Device Identifier (DI) Information

Brand Name: Thermo Scientific Protocol™ Parasitology System
Version or Model: 23-005-38
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Fisher Diagnostics

Primary DI Number: 00845275005011
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 183998769 *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):	No
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?
42674	Trichrome Blue/Ryan Blue solution IVD	A trichrome blue or Ryan blue solution intended to be used alone, or in combination with other solutions/stains, for the visualization of biological/clinical specimen tissue structures and/or intra/extracellular elements.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HYW	Stain, Trichrome, Mallory'S

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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1b110fb4-4590-4428-80c2-cad4925ffb78
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 16, 2016