- Physicians Office Resource

BUP (Buprenorphine) 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORP.® BUP RGT. KIT BL-424 - BL424

Device Description

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

Environmental Conditions

Special Storage Condition, Specify

Kit can be expected to perform satisfactorily until the expiration date if stored in the refrigerator at 2-8°C.

Special Storage Condition, Specify

Reagent is stable on board a clinical analyzer for 28 days when stored at 2 to 8°C

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

Total Volume: 20 Milliliter

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

Total Volume: 8 Milliliter

Total Volume: 20 Milliliter
Kit contains 2 R1 and 2 R2 bottles and 1 package insert
Total Volume: 8 Milliliter

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

Code: DJG

Device Name: Enzyme Immunoassay, Opiates

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: 862.3650

Third Party Flag: Y

Medical Specialty: TX

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

Device Identifiers

Device Id: 00817302020854

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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