AccessGUDID - DEVICE: Epredia (00673693088145)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: Differentiating Solution
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 74211
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693088145
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: Differentiating Solution is intended to be used as an aid in hematoxylin staining for the diagnosis of general pathology specimens. Differentiating Solution is an acid alcohol solution to be used with the Modified Harris Hematoxylin. It is formulated as a standard 1% hydrochloric acid in 70% alcohol solution and will provide consistent differentiation results. Differentiating Solution’s mode of action is that it aggressively reacts with the tissue dye-lake complex in nuclear chromatin, resulting in the removal of the stain. Due to weak bonding in the cytoplasm, hematoxylin in this area is also easily and completely removed. Generally, two to four quick dips will be adequate for differentiation when using Differentiating Solution, followed by a 1-minute water rinse to stop the reaction and fully remove the acid from the tissue.

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: c387c78c-7cc0-4578-9733-bd48127948ca
Public Version Date: September 09, 2024
Public Version Number: 1
DI Record Publish Date: August 30, 2024