AccessGUDID - DEVICE: Epredia (00673693088121)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: Clarifier™ 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7402
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693088121
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: Clarifier™ 2 is an aqueous glacial acetic acid rinse designed to eliminate background staining sometimes caused by excessive adhesives in the water bath such as gelatin. Clarifier™ 2 selectively removes hematoxylin staining from excess adhesive without affecting nuclear staining. This product is only effective with progressive staining an should not be used with regressive stains. Clarifier 2 was designed to be used in histology only. Clarifier™ 2 is designed for use after staining with progressive hematoxylins. After tissues have been sufficiently stained with a progressive hematoxylin, slides are removed from the stain and excess hematoxylin is removed by rinsing the sections in water. The sections are then placed into Clarifier™ 2 for 20 seconds to 40 seconds. A 1-minute water rinse should follow as this stops the reaction and rinses excess acid from the tissue section.

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?
43584	Acid-alcohol solution IVD	An acid-alcohol solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LED	Stains, Chemical Solution

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: d0d30bff-3dd4-42a2-95b7-28f7ad05f493
Public Version Date: September 09, 2024
Public Version Number: 1
DI Record Publish Date: August 30, 2024