FLAER FL2

GUDID 00628451099369

FLAER(Alexa 488 proaerolysin variant) solid format-ASR

Cedarlane Corporation

Fluorescein-labelled aerolysin (FLAER) test IVD, reagent

• Primary Device ID: 00628451099369
• NIH Device Record Key: f106fd05-4aec-416d-bdf3-2d074bfb3ab0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLAER
• Version Model Number: FL2
• Catalog Number: FL2
• Company DUNS: 243928822
• Company Name: Cedarlane Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Weight: 50 Microgram
• Weight: 50 Microgram
• Weight: 50 Microgram
• Weight: 50 Microgram
• Weight: 50 Microgram
• Weight: 50 Microgram
• Weight: 50 Microgram
• Weight: 50 Microgram
• Weight: 50 Microgram

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628451099369 [Primary]
GS1	06284510990363 [Previous]

FDA Product Code

• MVU: Reagents, Specific, Analyte

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-13
• Device Publish Date: 2024-12-05

On-Brand Devices [FLAER]

• 06284510990370: FLAER (Alexa 488 proaerolysin variant) liquid format-ASR
• 06284510990363: FLAER(Alexa 488 proaerolysin variant) solid format-ASR
• 06284510990356: FLAER (Alexa 488 proaerolysin variant) liquid format-ASR
• 06284510990349: FLAER (Alexa 488 proaerolysin variant) solid format-ASR
• 00628451099376: FLAER (Alexa 488 proaerolysin variant) liquid format-ASR
• 00628451099369: FLAER(Alexa 488 proaerolysin variant) solid format-ASR
• 00628451099352: FLAER (Alexa 488 proaerolysin variant) liquid format-ASR
• 00628451099345: FLAER (Alexa 488 proaerolysin variant) solid format-ASR