M12016
Mast Assure Escherichia coli O111 Antiserum - M12016
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative detection of antigens from multiple strains of Escherichia coli (E. coli) bacteria [e.g., O86: K61, O114: K90, O125: K70, O127: K63, O128: K67, O44: K74, O112: K66, O124: K72, O142: K86] isolated by culture from a clinical specimen, using an agglutination 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: 15060392376260
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