AccessGUDID - DEVICE: FluoroQuench Acridine Orange/Ethidium Bromide

GUDID

Device Identifier (DI) Information

Brand Name: FluoroQuench Acridine Orange/Ethidium Bromide - 100ml
Version or Model: N/A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FQAE100
Company Name: ONE LAMBDA, INC.

Primary DI Number: 00812117015897
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118289289 *Terms of Use

Device Description: FluoroQuench products are used to fluorescently stain and fix lymphocytes in the microcytotoxicity assays.

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:	Yes
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?
15599	Microscope slide stainer IVD	An automated mains electricity (AC-powered) laboratory instrument intended to be used to stain blood, tissue and/or other clinical specimens fixed to microscope examination slides, using one or more biological or cytochemical staining solutions in preparation for subsequent microscopic analysis. The device operates with minimal technician involvement and complete automation of all procedural steps.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KQC	Stains, Hematology

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 2 and 5 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e7052dd7-a432-41c9-877c-fa719f8c489b
Public Version Date: July 02, 2018
Public Version Number: 1
DI Record Publish Date: May 31, 2018