The Premier EHEC test is a rapid in vitro microwell EIA for the detection of Shiga Toxins I and II (Verotoxins) in stool specimens, broth cultures, from individual colonies or colony sweeps of agar plates. The Premier EHEC test is intended for use as an aid in the diagnosis of enterohemorrhagic E. coli (EHEC) infections.
PREMIER EHEC - 608096
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Escherichia coli (E. coli) bacteria in a clinical specimen and/or culture isolate, using an 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: GNA
Device Name: Antisera, All Types, Escherichia Coli
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: MI
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: 866.3255
Third Party Flag: N
Medical Specialty: MI
Device IdentifiersDevice Id: 00840733101724
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