Product Code: KTS
FDA class 2
21 CFR 866.5510
Second Antibody (Species Specific Anti-Animal Gamma Globulin)
Immunology
The Second Antibody (Species Specific Anti-Animal Gamma Globulin) is an immunological reagent used in double-antibody immunoassay techniques, where it binds to a primary antibody-antigen complex to facilitate separation and quantification in diagnostic testing. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification prior to marketing. The product code is KTS, regulated under 21 CFR 866.5510, in the Immunology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
510(k)s
4
FEI Numbers
0
Registration Numbers
0
Unique Applicants
3
Years Active
3
Basic Information
- Product Code
- KTS
- Device Class
- FDA class 2
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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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 |
|---|---|---|---|---|
| K813508 | SAC-CEL | Dec 29, 1981 | Substantially Equivalent | Burroughs Wellcome Co. |
| K792637 | CENTRIA-SET TYPE D(ANTI-SHEEP/GOAT) | Jan 11, 1980 | Substantially Equivalent | Union Carbide Corp. |
| K792636 | CENTRIA RADIOIMMUNOASSAY SEPARATION | Jan 11, 1980 | Substantially Equivalent | Union Carbide Corp. |
| K781070 | SECOND ANTIBODY | Aug 10, 1978 | Substantially Equivalent | Pcl-Ria, Inc. |