Antigens, All, Leptospira Spp.
The Antigens, All, Leptospira Spp. is a comprehensive set of antigens derived from all serogroups of Leptospira species, used in laboratory serological assays to detect and serogroup leptospiral infections. As an FDA Class 2 device, it carries moderate risk and requires 510(k) premarket clearance. The product code is GRY, regulated under 21 CFR 866.3350 in the Microbiology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- GRY
- Device Class
- FDA class 2
- Regulation Number
- 866.3350
- 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 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K002024 | PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA | Nov 22, 2000 | Substantially Equivalent | Panbio, Inc. |
| K880417 | LEPTOSPIROSIS IHA | Apr 12, 1988 | Substantially Equivalent | Hillcrest Biologicals |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.