This product is intended for use in the calibration of Myoglobin immunoturbidimetric assays.

This product is intended for use in the calibration of Myoglobin immunoturbidimetric assays.
MYO CAL SET - MY2456

Device Description

A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of myoglobin in a clinical specimen.

Environmental Conditions

Special Storage Condition, Specify

Reconstituted calibrators are stable for 30 days when stored at +2ºC and +8ºC in the absence of contamination. The calibrators may be frozen for up to 6 months at –20ºC.

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: DDR

Device Name: Myoglobin, Antigen, Antiserum, Control

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: IM

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: 866.5680

Third Party Flag: Y

Medical Specialty: IM

Device Identifiers

Device Id: 05055273204681

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