Thyroglobulin, Antigen, Antiserum, Control
This is an immunological reagent kit for detecting and measuring thyroglobulin, the large glycoprotein produced by thyroid follicular cells that serves as a precursor for thyroid hormone synthesis and as a tumor marker in differentiated thyroid cancer monitoring. The kit includes antigen, antiserum, and control components for clinical laboratory immunoassays. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DDC, regulated under 21 CFR 866.5870, within the Immunology specialty.
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Basic Information
- Product Code
- DDC
- Device Class
- FDA class 2
- Regulation Number
- 866.5870
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
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 |
|---|---|---|---|---|
| K023592 | SERAQUEST ANTI-THYROGLOBULIN | Jan 06, 2003 | Substantially Equivalent | Quest Intl., Inc. |
| K012208 | ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895 | Sep 07, 2001 | Substantially Equivalent | Beckman Coulter, Inc. |
| K000363 | MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM | Feb 18, 2000 | Substantially Equivalent | Zeus Scientific, Inc. |
| K991610 | ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. | Jun 25, 1999 | Substantially Equivalent | Zeus Scientific, Inc. |
| K991179 | ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM | Jun 17, 1999 | Substantially Equivalent | Zeus Scientific, Inc. |
| K971835 | ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA | Jul 03, 1997 | Substantially Equivalent | Monobind |
| K953066 | SERODIA ATG | Aug 14, 1995 | Substantially Equivalent | Fujirebio America, Inc. |
| K943625 | AUTOSTAT II ANTI-THYROGLOBULIN | Dec 22, 1994 | Substantially Equivalent | Cogent Diagnotics , Ltd. |
| K936010 | THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY | Jul 18, 1994 | Substantially Equivalent | Biomerica, Inc. |
| K930486 | QUANTA LITE(TM) THYROID T ELISA | Mar 15, 1993 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K865020 | SERA-TEK THYROGLOBULIN ANTIBODY TEST | Feb 02, 1987 | Substantially Equivalent | Miles Laboratories, Inc. |
| K780874 | THYMUNE-T | Jun 14, 1978 | Substantially Equivalent | Burroughs Wellcome Co. |
| K780873 | THYMUNE-M | Jun 14, 1978 | Substantially Equivalent | Burroughs Wellcome Co. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.