ImmunoCard STAT! CAMPY is an immunochromatographic rapid test for the qualitative detection of specific Campylobacter antigens in human stool.

ImmunoCard STAT! CAMPY is an immunochromatographic rapid test for the qualitative detection of specific Campylobacter antigens in human stool.
ImmunoCard STAT! CAMPY - 751530

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple species of Campylobacter bacteria in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to detect infection with Campylobacter bacteria which may include C. coli, C. fetus and C. jejuni. It is not intended to be used for self-testing.

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Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LQP

Device Name: Campylobacter Spp.

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 866.3110

Third Party Flag: Y

Medical Specialty: MI

Device Id: 00840733101373

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