BARB (Barbiturates) 3 x 375 tests
CAROLINA LIQUID CHEMISTRIES CORP.® BARB RGT. KIT ST417 - ST417
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of barbiturates in a clinical specimen, using an enzyme immunoassay (EIA) method.
Environmental Conditions
- Reagent is stable when stored at 2-8° C until expiration date
- 8.00
- 2.00
Device Sizes
- Total Volume: 26 Milliliter
- Total Volume: 63 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: DIS
Device Name: Enzyme Immunoassay, Barbiturate
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: 862.3150
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
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
Device IdentifiersDevice Id: 00817302021097
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