Syva® Emit® Amikacin Assay
Syva® Emit® Amikacin Assay - 10445383
Device Description
A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the antimicrobial drug amikacin in a clinical specimen, using a enzyme immunoassay (EIA) method.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: KLQ
Device Name: Radioimmunoassay, Amikacin
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: 862.3035
Third Party Flag: Y
Medical Specialty: TX
Device IdentifiersDevice Id: 00842768001543
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