Antigen, Cf, Psittacosis (Chlamydia Group)
The Psittacosis (Chlamydia Group) CF (Complement Fixation) Antigen is a serological reagent used in complement fixation tests to detect antibodies against Chlamydia group organisms, used in the diagnosis of psittacosis and other chlamydial infections. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is GPW, regulated under 21 CFR 866.3120 in the Microbiology specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- GPW
- Device Class
- FDA class 1
- Regulation Number
- 866.3120
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K872700 | YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN | Oct 15, 1987 | Substantially Equivalent | Sita, Inc. |
| K843654 | CHLAMYDIA | Aug 08, 1985 | Substantially Equivalent | Institute Virion , Ltd. |
| K844868 | CHLAMYDIA GROUP CF ANTIGEN | Mar 05, 1985 | Substantially Equivalent | Hillcrest Biologicals |
| K811570 | ANTIBODY TO CHLAMYDIA TRACHOMATIS | Jul 23, 1981 | Substantially Equivalent | Electro-Nucleonics Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.