Transferrin SPQ III Antibody Reagent Set
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K983880 FDA 510(k)
- FDA Product Code
- DDG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5880 FDA 510(k)
- Regulation Number
- 866.5880 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Transferrin SPQ III Antibody Reagent Set is an in vitro diagnostic kit used for the quantitative measurement of transferrin levels in human serum. It utilizes immunoprecipitin analysis to detect and quantify transferrin.
The device is manufactured by DiaSorin, Inc. and is supplied as a reagent set. It is a class II device with FDA 510(k) clearance (K983880) and is regulated under product code DDG with regulation number 866.5880.
Frequently asked questions
What is the Transferrin SPQ III Antibody Reagent Set used for?
The Transferrin SPQ III Antibody Reagent Set is an in vitro diagnostic kit used for the quantitative measurement of transferrin levels in human serum. It utilizes immunoprecipitin analysis to detect and quantify transferrin.
How is the Transferrin SPQ III Antibody Reagent Set supplied?
The device is supplied as a reagent set by DiaSorin, Inc. It is manufactured as a complete kit containing all necessary components for the quantitative measurement of transferrin in human serum samples.
What is the regulatory status of the Transferrin SPQ III Antibody Reagent Set?
The Transferrin SPQ III Antibody Reagent Set is a class II device with FDA 510(k) clearance (K983880). It is regulated under product code DDG with regulation number 866.5880 and was cleared through the traditional review process.
Is the Transferrin SPQ III Antibody Reagent Set single-use or reusable?
The device is supplied as a reagent set for in vitro diagnostic use. The specific usage instructions regarding single-use or reuse would be detailed in the product's instructions for use, which should be consulted for proper handling and disposal procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TRANSFERRIN SPQ III ANTIBODY REAGENT SET (K983880) — FDA 510 (k ..., Transferrin Spq Iii Antibody Reagent Set 510 (k) FDA Premarket ..., Transferrin Spq Iii Antibody Reagent Set - Beudamed, 510(k) K983880 — TRANSFERRIN SPQ III ANTIBODY REAGENT SET
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K983880 | Class II | Active |
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Manufacturer
- Manufacturer
- Diasorin Inc.
- FDA Applicant
- DiaSorin, Inc.
Sources (1)
- FDA 510(k) K983880 24 fields · synced Sep 24, 2026