6AM (6-Acetylmorphine) 3 x 375 tests


Product Overview

6AM (6
CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT ST425 - ST425


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of 6-acetyl morphine 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.
  • Storage Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00

  • Device Sizes

  • 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
    • Total Volume: 63 Milliliter
    • Total Volume: 26 Milliliter


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    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: DKB

    Device Name: Calibrators, Drug Mixture

    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: DIF

    Device Name: Drug Mixture 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: 00817302020793

    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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