Staphylococcus Aureus Protein A Insoluble
Staphylococcus aureus protein A insoluble is a microbiology reagent in which protein A from S. aureus is bound to an insoluble matrix, used as a tool for the purification of immunoglobulins and in serological testing applications. The device is FDA Class 1, the lowest risk category, requiring only general controls without premarket notification. It carries product code LHJ 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
- LHJ
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K940557 | STAPHYTECT-OD | Jul 28, 1994 | Substantially Equivalent | Unipath , Ltd. |
| K842709 | IMMUSTAPH LATEX AGGLUTINATION KIT | Aug 03, 1984 | Substantially Equivalent | Immucell Corp. |
| K812181 | STAPHYLOCOCCAL PROTEIN A INSOLUBLE | Aug 25, 1981 | Substantially Equivalent | Oxoid U.S.A., 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.