Synchron 469785

GUDID 15099590221287

Phenobarbital Reagent (PHE 2 x 100)

Beckman Coulter, Inc.

Phenobarbital IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 15099590221287
• NIH Device Record Key: 7374e768-2613-407f-a545-ca5e68a57402
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synchron
• Version Model Number: 469785
• Catalog Number: 469785
• 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	15099590221287 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955644

FDA Product Code

• LFN: Nephelometric Inhibition Immunoassay, Phenobarbital

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

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• 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)
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• 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)
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• 15099590575090: Alanine Aminotransferase Reagent (ALT- 2 x 300)
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• 15099590233501: Glucose Reagent (Glucose Oxidase)
• 15099590233495: Urea Nitrogen (BUN) Reagent
• 15099590233488: SYNCHRON Systems CO2 Acid Reagent
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• 15099590233402: SYNCHRON Systems AQUA CAL 1
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• 15099590233334: Sample Diluent 1 DIL1
• 15099590233327: Total Protein Reagent
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• 15099590233259: SYNCHRON Systems SYNCHRON PROTEIN CALIBRATOR LEVELS 1 and 2