Synchron 465993

GUDID 15099590222727

SYNCHRON SYSTEMS Ammonia/Alcohol Control LEVEL 2

Beckman Coulter, Inc.

Multiple clinical chemistry analyte IVD, control

• Primary Device ID: 15099590222727
• NIH Device Record Key: 14d754e1-1989-4e6c-bb9c-fea7278c02eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synchron
• Version Model Number: 465993
• Catalog Number: 465993
• 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	15099590222727 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934467

FDA Product Code

• DKC: Alcohol Control Materials

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: 2016-08-24

On-Brand Devices [Synchron]

• 15099590669706: Unicel DxC SYNCHRON Systems HDL Calibrator
• 15099590663438: SYNCHRON Systems No Foam DxC
• 15099590625733: Enzymatic Creatinine Reagent (CR-E 2 x 200)
• 15099590625726: Enzymatic Carbon Dioxide (CO2E 2 x 300)
• 15099590625719: Albumin Reagent (ALB 2 x 300)
• 15099590625689: Alkaline Phosphatase Reagent (ALP 2 x 400)
• 15099590625672: Alanine Aminotransferase Reagent (ALT 2 x 400)
• 15099590625665: Aspartate Aminotransferase Reagent (AST 2 x 400)
• 15099590625658: Lactate Dehydrogenase Reagent (LD 2 x 300)
• 15099590625641: Gamma-Glutamyl Transferase Reagent (γ-GT 2 x 400)
• 15099590625634: Magnesium Reagent (MG 2 x 100)
• 15099590625627: Direct LDL Cholesterol Reagent (LDLD 2 x 100)
• 15099590625610: Total Protein Reagent (TP 2 x 300)
• 15099590625603: Direct Bilirubin Reagent (DBIL 2 x 300)
• 15099590625597: Total Bilirubin Reagent (TBIL 2 x 400)
• 15099590575281: Uric Acid Reagent (URIC 2 x 300)
• 15099590575274: Urea Reagent (UREA 2 x 300)
• 15099590575212: Creatine Kinase Reagent (CK 2 x 400)
• 15099590575205: Alanine Aminotransferase Reagent (ALT 2 x 200)
• 15099590575199: Creatine Kinase Reagent (CK 2 x 200)
• 15099590575175: Lactate Dehydrogenase Reagent (LD-P 2 x 200)
• 15099590575168: Alkaline Phosphatase Reagent (ALP 2 x 200)
• 15099590575151: Microprotein Reagent (M-TP 2 x 50)
• 15099590575120: Direct Bilirubin Reagent (DBIL 2 x 200)
• 15099590575113: Cholesterol Reagent (CHOL 2 x 300)
• 15099590575106: Creatine Kinase Reagent (N-Acetyl-L-cysteine) (CK- 2 x 200)
• 15099590575090: Alanine Aminotransferase Reagent (ALT- 2 x 300)
• 15099590575083: Alanine Aminotransferase Reagent (ALT- 2 x 100)
• 15099590575076: Aspartate Aminotransferase Reagent (AST- 2 x 100)
• 15099590575069: Transferrin Reagent (TRFN 2 x 150)
• 15099590233877: SYNCHRON Control Multilevel Comprehensive Chemistry Control Serum
• 15099590233860: Cartridge Chemistry Wash Solution (CCWA 2 x 300)
• 15099590233525: SYNCHRON Systems Creatinine Reagent
• 15099590233518: SYNCHRON Systems CO2 Alkaline Buffer
• 15099590233501: Glucose Reagent (Glucose Oxidase)
• 15099590233495: Urea Nitrogen (BUN) Reagent
• 15099590233488: SYNCHRON Systems CO2 Acid Reagent
• 15099590233471: PVT5
• 15099590233426: SYNCHRON Systems AQUA CAL 3
• 15099590233419: SYNCHRON Systems AQUA CAL 2
• 15099590233402: SYNCHRON Systems AQUA CAL 1
• 15099590233389: SYNCHRON Systems CAL 1 Calibrator 1
• 15099590233372: Immunoglobulin M Reagent (Ig-M 2 x 150)
• 15099590233365: Iron Reagent (FE 2 x 200)
• 15099590233358: SYNCHRON Systems Phosphorus Reagent
• 15099590233341: SYNCHRON Systems Albumin Reagent
• 15099590233334: Sample Diluent 1 DIL1
• 15099590233327: Total Protein Reagent
• 15099590233310: SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR
• 15099590233259: SYNCHRON Systems SYNCHRON PROTEIN CALIBRATOR LEVELS 1 and 2