Staphylococcus Aureus Somatic Antigens
Staphylococcus aureus somatic antigens are microbiological reagents derived from the cell body of S. aureus bacteria, used in laboratory tests to detect antibodies against this pathogen in patient serum and to support the serological diagnosis of staphylococcal infections. The device is FDA Class 1, the lowest risk category, requiring only general controls without premarket notification. It carries product code LHT and is regulated under 21 CFR 866.3700 within the Microbiology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LHT
- Device Class
- FDA class 1
- Regulation Number
- 866.3700
- 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 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K874303 | STAPHYLASE TEST | Nov 06, 1987 | Substantially Equivalent | Oxoid U.S.A., Inc. |
| K863025 | SERO-STAT R II STAPHYLOCOCCUS TEST | Sep 15, 1986 | Substantially Equivalent | Scott Laboratories, Inc. |
| K820683 | STAPHYLOCOCCUS LATEX AGGLUTINATION KIT | Apr 14, 1982 | Substantially Equivalent | American Scientific Products |
| K820531 | ENDO-STAPH TEICHOIC ACID ANTIBODY KIT | Apr 14, 1982 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K820347 | ACCU-STAPH | Mar 04, 1982 | Substantially Equivalent | Carr-Scarborough Microbiologicals, Inc. |
| K812434 | DIAGNOSTIC KITS & KIT COMPONENTS | Sep 23, 1981 | Substantially Equivalent | Diagnostica, Inc. |
| K812376 | SHEEP BLOOD IN ALSEVER'S, CITR., DEFIBR | Sep 09, 1981 | Substantially Equivalent | Dutchland Laboratories, Inc. |
| K812375 | BABY CHICK BLOOD IN ALSEVER'S | Sep 09, 1981 | Substantially Equivalent | Dutchland Laboratories, Inc. |
| K812374 | ADULT CHICKEN BLOOD IN ALSEVER'S, C., D. | Sep 09, 1981 | Substantially Equivalent | Dutchland Laboratories, Inc. |
| K812373 | RABBIT BLOOD IN ALSEVER'S, CITR., DEFIBR | Sep 09, 1981 | Substantially Equivalent | Dutchland Laboratories, Inc. |
| K812372 | GUINEA PIG BLOOD IN ALSEVER'S, CIT., DEF | Sep 09, 1981 | Substantially Equivalent | Dutchland Laboratories, Inc. |
| K812368 | RAT BLOOD IN ALSEVER'S, CITRATED | Sep 09, 1981 | Substantially Equivalent | Dutchland Laboratories, Inc. |
| K812367 | GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD) | Sep 09, 1981 | Substantially Equivalent | Dutchland Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.