ETHA (Alcohol) w/ cal - UDR CX/LX/DXC 2 x 150 tests

ETHA (Alcohol) w/ cal
CAROLINA LIQUID CHEMISTRIES CORP.® ETHYL ALCOHOL CC421 - CC421

A collection of reagents and other associated materials intended to be used for the quantitative measurement of ethyl alcohol (ETOH) in a clinical specimen, using an enzyme spectrophotometry method. It is typically used to assess for alcohol intoxication and in the management of alcoholism.

• Total Volume: 5 Milliliter
• Total Volume: 32 Milliliter
• Kit contains 2 Reagent cartridges, 1 Calibrator and 1 package insert
• Total Volume: 11 Milliliter

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DNN

Device Name: Calibrators, Ethyl Alcohol

Device Class: 2

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: 862.3200

Third Party Flag: N

Medical Specialty: TX

Code: DIC

Device Name: Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 862.3040

Third Party Flag: Y

Medical Specialty: TX

Code: DKC

Device Name: Alcohol 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 Id: 00817302021387

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