The Access Myoglobin Calibrators are intended to calibrate the Access Myoglobin assay for the quantitative determination of myoglobin levels in human serum and plasma using the Access Immunoassay Systems.


Product Overview

The Access Myoglobin Calibrators are intended to calibrate the Access Myoglobin assay for the quantitative determination of myoglobin levels in human serum and plasma using the Access Immunoassay Systems.
Access Myoglobin Calibrators - 973244


Device Description

A collection of reagents and other associated materials intended to be used for the quantitative measurement of myoglobin in a clinical specimen, using a chemiluminescent immunoassay method.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: JIT

Device Name: Calibrator, Secondary

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.1150

Third Party Flag: N

Medical Specialty: CH


Device Identifiers

Device Id: 15099590231699

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


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