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