AccessGUDID - DEVICE: Epredia (00673693106870)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: Track 300™ Automated Differential System Immersion Oil
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M3000
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693106870
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: Resolve™ Immersion Oil is a clear, colorless oil that allows light transmission throughout most of the UV-VIS spectrum. Resolve Immersion Oil is manufactured using a proprietary process that removes most interfering substances, allowing for superb visualization of microscopic samples under high (oil immersion) magnification. Resolve is available in both low viscosity and high viscosity, is non-drying and non-hardening, and has a refractive index of 1.515. It contains no PCBs, eliminating toxicity and disposal problems. Consult your microscope instruction manual for compatibility. Trak 300™ oil is intended for use with the HEMATRAK® automated differential system. The oil does not contain PCBs and is safe to use with valuable optics. The refractive index is 1.515.

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?
62690	Molecular grade procedure oil IVD	An inert oil (e.g., silicone oil, mineral oil, immersion oil) intended to be used as a barrier/seal/partitioning agent to minimize or prevent sample carryover and/or evaporation in an in vitro diagnostic assay performed on a clinical specimen (e.g., using a microwell plate), and/or to occupy the space between a microscope slide and a microscope objective lens to remove air and enhance image resolution of the microscope.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PPM	General Purpose Reagent

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: 909b757a-1243-4970-97b3-051cb3e02684
Public Version Date: August 06, 2024
Public Version Number: 1
DI Record Publish Date: July 29, 2024