ACETAMINOPHEN PLUS 1


Product Overview

ACETAMINOPHEN PLUS 1 - ACETA+ 1 S F BD


Device Description

A material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple drugs used for different types of therapies (e.g., antibiotic, anticonvulsant, and cardiovascular) 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: B80010095200061

Device Type: Package

DeviceId Issuing Agency: HIBCC

Contains DI Number: B80010095200060

Package Quantity: 4

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box


Device Id: B80010095200060

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: B80010095200062

Device Type: Package

DeviceId Issuing Agency: HIBCC

Contains DI Number: B80010095200060

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box


Device Id: B80010095200063

Device Type: Package

DeviceId Issuing Agency: HIBCC

Contains DI Number: B80010095200060

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box


Device Id: B80010095200066

Device Type: Package

DeviceId Issuing Agency: HIBCC

Contains DI Number: B80010095200060

Package Quantity: 25

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box


Device Id: B80010095200067

Device Type: Package

DeviceId Issuing Agency: HIBCC

Contains DI Number: B80010095200060

Package Quantity: 50

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box


Device Id: B80010095200068

Device Type: Package

DeviceId Issuing Agency: HIBCC

Contains DI Number: B80010095200060

Package Quantity: 100

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box


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