AMY AY1582

GUDID 05055273200577

The amylase test system is intended for the quantitative in vitro determination of Amylase in serum, plasma or urine.

RANDOX LABORATORIES LIMITED

Amylase isoenzyme IVD, reagent

• Primary Device ID: 05055273200577
• NIH Device Record Key: c65b19dc-ddb0-4039-8bcc-add2b3982eaa
• Commercial Distribution Discontinuation: 2016-09-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AMY
• Version Model Number: AY1582
• Catalog Number: AY1582
• Company DUNS: 227530649
• Company Name: RANDOX LABORATORIES LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +442894451070
• Email: technical.services@randox.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stable for 21 days at +2 to + 8°C once reconstituted.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273200577 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953211

FDA Product Code

• CIJ: Saccharogenic, Amylase

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-09

On-Brand Devices [AMY]

• 05055273200676: An α-amylase test system is a device intended for the quantitative in vitro determination of α
• 05055273200652: An α-amylase test system is a device intended for the quantitative in vitro determination of α
• 05055273200645: An α-amylase test system is a device intended for the quantitative in vitro determination of α
• 05055273200607: An α-amylase test system is a device intended for the quantitative in vitro determination of α
• 05055273200584: The AMY method used on the Dimension® clinical chemistry system is an in vitro diagnostic test
• 05055273200577: The amylase test system is intended for the quantitative in vitro determination of Amylase in se
• 05055273200560: The amylase test system is intended for the quantitative in vitro determination of Amylase in se