ETHA (Alcohol) w/ cal 2 x 625 tests

ETHA (Alcohol) w/ cal 2 x 625 tests
CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT AU-421 - AU-421

Device Description

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

Environmental Conditions

Special Storage Condition, Specify

Reagent is stable when stored at 2-8° C until expiration date

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

Total Volume: 60 Milliliter

Total Volume: 25 Milliliter

Total Volume: 5 Milliliter

Kit contains 2 R1, 2 R2 bottles, 1 Calibrator and 1 package insert

Total Volume: 60 Milliliter
Total Volume: 25 Milliliter
Total Volume: 5 Milliliter
Kit contains 2 R1, 2 R2 bottles, 1 Calibrator and 1 package insert

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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: 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

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

Device Identifiers

Device Id: 00817302021370

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