JAS Diagnostics

GUDID 00817274021293

CK MB ISOENZYME POWDER

DREW SCIENTIFIC, INC.

Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry

• Primary Device ID: 00817274021293
• NIH Device Record Key: 5078b337-1eb6-428d-b1c6-d1fe12ea67c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JAS Diagnostics
• Version Model Number: CKMB-BUP
• Company DUNS: 144968104
• Company Name: DREW SCIENTIFIC, 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: false
• Lot Batch: true
• 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

Customer Support Contacts

• Phone: 1-305-324-2300
• Email: customersupport@erbadiagnostics.com
• Phone: 1-305-324-2300
• Email: customersupport@erbadiagnostics.com
• Phone: 1-305-324-2300
• Email: customersupport@erbadiagnostics.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817274021293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942958

FDA Product Code

• JHW: U.V. Method, Cpk Isoenzymes

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 [JAS Diagnostics]

• 00817274022856: HDL CHOLESTEROL (4x 125mL R1, 4x 42mL R2)
• 00817274022849: AMYLASE BULK LIQUID
• 00817274022832: GLUCOSE HEXOKINASE (2 x 125mL)
• 00817274022825: Microprotein Standard (1 x 10 mL)
• 00817274022818: Microprotein Standard
• 00817274022801: Microalbumin Multi-Calibrator (Levels A-F)
• 00817274022795: Microalbumin Control Kit (L1 & L2)
• 00817274022788: Microalbumin Reagent (4 x 20 mL R1, 2 x 10 mL)
• 00817274022771: AMYLASE Powder PALS (1 x1L)
• 00817274022702: CHOLESTEROL STD (1 X 1L)
• 00817274022696: ALBUMIN STANDARD (1x 1L)
• 00817274022672: UREA NITROGEN STANDARD (1x 1L)
• 00817274022641: LIPID CALIBRATOR (1 x 3 mL) UV
• 00817274022634: LIPID CALIBRATOR (1 x 3 mL)
• 00817274022627: OLYMPUS WASH SOLUTION - CONCENTRATE (6 x 2L)
• 00817274022597: LDL, (2 x 30 mL R1, 2 x 10mL R2)
• 00817274022580: Iron Liquid Reagent (2 x 125 mL R1, 1 x 15 mL R2)
• 00817274022566: TOTAL PROTEIN STANDARD (3mL)
• 00817274022559: CALCIUM Standard (1 x 1L)
• 00817274022542: GLUCOSE HEXOKINASE (1 x 1L)
• 00817274022535: Triglycerides Powder Bulk (20L)
• 00817274022528: TOTAL BILIRUBIN LIQUID (1 x 1L R1, 1 X 15 mL Sodium Nitrite)
• 00817274022511: DIRECT BILIRUBIN LIQUID (1 x 1L R1, 1 x 15 mL Sodium Nitrite)
• 00817274022498: CARBON DIOXIDE LIQUID 405nm (2x 125mL)
• 00817274022481: Phosphorus Liquid Reagent (2 x 125 mL)
• 00817274022474: TOTAL PROTEIN LIQUID REAGENT (1 x 1L)
• 00817274022467: Phosphorus Liquid Reagent (1 x 1L)
• 00817274022450: Calcium Arsenazo Reagent(1 x 1L)
• 00817274022443: Alkaline Phosphatase Bulk Liquid R1 2.5 L
• 00817274022436: Alkaline Phosphatase Bulk Liquid R1 10 L
• 00817274022429: ABS OLYMPUS WASH SOLUTION - CONCENTRATED (5 X 4L)
• 00817274022382: DGLab HDL/LDL CHOLESTEROL CALIBRATOR (3x 1mL)
• 00817274022375: LIPID CALIBRATOR (3x 1mL)
• 00817274022368: Chemistry Control Level 2 (5mL)
• 00817274022351: CHEMISTRY CONTROL LEVEL 1 ( 5mL)
• 00817274022337: CREATININE (5 x 50mL)
• 00817274022320: AMYLASE PALS BULK (20L CUBITAINER)
• 00817274022313: ALBUMIN BULK LIQUID (20 L Cubitainers)
• 00817274022306: HDL/LDL CHOLESTEROL (LIPID) CONTROL LEVEL 1 (3mL)
• 00817274022290: HDL/LDL CHOLESTEROL (LIPID) CONTROL LEVEL 2 (3mL)
• 00817274022252: HDL CHOLESTEROL (2x 125mL R1, 2x 42mL R2)
• 00817274022245: IRON STANDARD BULK
• 00817274022221: XL-400 Clinical Chemistry Analyzer
• 00817274022214: XL-200 Clinical Chemistry Analyzer
• 00817274022207: URIC ACID STANDARD (1x 3mL) UV
• 00817274022191: URIC ACID REAGENT PALS BULK (in 20 dry Liter bottles)
• 00817274022184: URIC ACID LIQUID REAGENT (1x 1L)
• 00817274022177: URIC ACID LIQUID (2x 125mL + 1x 3mL Standard)
• 00817274022160: URIC ACID LIQUID (1 x 1 Liter + 1 x 5mL Standard)
• 00817274022153: URIC ACID LIQ BULK (in 20L cub)