AccessGUDID - DEVICE: FLAER (00628451099352)

GUDID

Device Identifier (DI) Information

Brand Name: FLAER
Version or Model: FL1S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FL1S
Company Name: Cedarlane Corporation

Primary DI Number: 00628451099352
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 243928822 *Terms of Use
Previous DI: 06284510990356

Device Description: FLAER (Alexa 488 proaerolysin variant) liquid format-ASR

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?
63725	Fluorescein-labelled aerolysin (FLAER) test IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of glycophosphatidylinositol-deficient blood cells from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVU	Reagents, Specific, Analyte

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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 25 Microgram

Device Record Status

Public Device Record Key: 9a65cf08-f357-4029-b62e-584275c5be58
Public Version Date: December 13, 2024
Public Version Number: 1
DI Record Publish Date: December 05, 2024