JAS Diagnostics

GUDID 00817274021293

CK MB ISOENZYME POWDER

DREW SCIENTIFIC, INC.

Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry
Primary Device ID00817274021293
NIH Device Record Key5078b337-1eb6-428d-b1c6-d1fe12ea67c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameJAS Diagnostics
Version Model NumberCKMB-BUP
Company DUNS144968104
Company NameDREW SCIENTIFIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-305-324-2300
Emailcustomersupport@erbadiagnostics.com
Phone1-305-324-2300
Emailcustomersupport@erbadiagnostics.com
Phone1-305-324-2300
Emailcustomersupport@erbadiagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100817274021293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JHWU.V. Method, Cpk Isoenzymes

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-09

On-Brand Devices [JAS Diagnostics]

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

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