DAU CALIBRATOR LEVEL 4


Product Overview

DAU CALIBRATOR LEVEL 4 - DAU CAL 4 V4 F SEMCE


Device Description

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple therapeutic drugs and drugs of abuse in a clinical specimen.


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: LAS

Device Name: Drug Specific Control Materials

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: TX

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: 862.3280

Third Party Flag: N

Medical Specialty: TX


Device Identifiers

Device Id: B80004240000040

Device Type: Primary

DeviceId Issuing Agency: HIBCC

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


Device Id: B80004240000041

Device Type: Package

DeviceId Issuing Agency: HIBCC

Contains DI Number: B80004240000040

Package Quantity: 4

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box


Device Id: B80004240000042

Device Type: Package

DeviceId Issuing Agency: HIBCC

Contains DI Number: B80004240000040

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box


Device Id: B80004240000043

Device Type: Package

DeviceId Issuing Agency: HIBCC

Contains DI Number: B80004240000040

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box


Device Id: B80004240000046

Device Type: Package

DeviceId Issuing Agency: HIBCC

Contains DI Number: B80004240000040

Package Quantity: 25

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box


Device Id: B80004240000047

Device Type: Package

DeviceId Issuing Agency: HIBCC

Contains DI Number: B80004240000040

Package Quantity: 50

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box


Device Id: B80004240000048

Device Type: Package

DeviceId Issuing Agency: HIBCC

Contains DI Number: B80004240000040

Package Quantity: 100

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box


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