AU

GUDID 15099590010058

α-Amylase

Beckman Coulter, Inc.

Total amylase IVD, kit, enzyme spectrophotometry

• Primary Device ID: 15099590010058
• NIH Device Record Key: 55a1a4bc-3c07-458b-ae18-400d1f03c882
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AU
• Version Model Number: OSR6106
• Company DUNS: 008254708
• Company Name: Beckman Coulter, Inc.
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590010058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924339

FDA Product Code

• CIW: Starch-Dye Bound Polymer, 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: 2016-09-24

On-Brand Devices [AU]

• 15099590670108: Urine CSF Albumin
• 15099590635565: URINE CREATININE CALIBRATOR
• 15099590635534: URINE CHEMISTRY CALIBRATOR
• 15099590140076: ISE Buffer Solution
• 15099590140069: ISE Mid Standard Solution
• 15099590140052: ISE Reference Solution
• 15099590140045: ISE Low Serum Standard
• 15099590140038: ISE High Serum Standard
• 15099590140021: ISE Low/High Urine Standard
• 15099590140014: ISE Internal Reference Solution
• 15099590140007: ISE Na+/K+ Selectivity Check Solution
• 15099590080884: D-Dimer Calibrator
• 15099590080860: Wash Solution
• 15099590080839: Prealbumin Calibrator
• 15099590080785: Serum Protein Multi-Calibrator 2
• 15099590080778: APO A1 & B Calibrator
• 15099590080761: Serum Protein Multi-Calibrator 1
• 15099590070588: D-Dimer Control
• 15099590070571: RF Latex Calibrator
• 15099590070564: CRP Latex Calibrator Highly Sensitive (HS) Set
• 15099590070557: CRP Latex Calibrator Normal (N) Set
• 15099590070519: LDL Cholesterol Calibrator
• 15099590070502: HDL Cholesterol Calibrator
• 15099590060213: Urea Stat/Urea Nitrogen Stat
• 15099590060206: Bicarbonate
• 15099590060183: Calcium Arsenazo
• 15099590060176: Total Bilirubin
• 15099590060169: Direct Bilirubin
• 15099590060152: Uric Acid
• 15099590060145: Triglyceride
• 15099590060114: Urea/Urea Nitrogen
• 15099590060091: Total Protein
• 15099590060084: Glucose
• 15099590060077: Creatinine
• 15099590060060: Cholesterol
• 15099590060039: AST
• 15099590060022: ALT
• 15099590060015: ALP
• 15099590060008: Albumin
• 15099590050405: Urea Stat/Urea Nitrogen Stat
• 15099590050085: AST
• 15099590020422: Urine CSF Albumin
• 15099590020408: LIH
• 15099590020385: Uric Acid
• 15099590020361: LDL-Cholesterol
• 15099590020354: HDL-Cholesterol
• 15099590020347: Urinary/CSF Protein
• 15099590020279: Iron
• 15099590020262: CK (NAC)
• 15099590020187: Bicarbonate