- Physicians Office Resource

THC (Cannabinoids) 3 x 375 tests
CAROLINA LIQUID CHEMISTRIES CORP.® THC50 RGT. KIT ST410A - ST410A

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) in a clinical specimen, using an enzyme immunoassay (EIA) method.

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: 63 Milliliter

Total Volume: 26 Milliliter

Kit contains 3 R1 and 3 R2 bottles and 1 package insert

Total Volume: 63 Milliliter
Total Volume: 26 Milliliter
Kit contains 3 R1 and 3 R2 bottles and 1 package insert

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: DLJ

Device Name: Calibrators, Drug Specific

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: 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

Code: LDJ

Device Name: Enzyme Immunoassay, Cannabinoids

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: 862.3870

Third Party Flag: Y

Medical Specialty: TX

Device Identifiers

Device Id: 00817302021776

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

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