Antisera, All Types, Listeria Monocytogenes
The Antisera, All Types, Listeria Monocytogenes is a collection of antisera used in laboratory serological assays to identify and type all serogroups of Listeria monocytogenes, the causative agent of listeriosis. It is an FDA Class 1 device, presenting the lowest risk, requiring only general controls and no premarket submission. The product code is GSH, regulated under 21 CFR 866.3355 in the Microbiology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- GSH
- Device Class
- FDA class 1
- Regulation Number
- 866.3355
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K791459 | AGGLUTINOTEST-LISTERIA | Sep 24, 1979 | Substantially Equivalent | Volu Sol Medical Industries |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.