Bio-Rad Coda Neonatal Galt Assay
FDA 510(k)Class II (US FDA 510(k))
by Bio-Rad
Identifiers
- 510(k) Number
- K993536 FDA 510(k)
- FDA Product Code
- KQP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1315 FDA 510(k)
- Regulation Number
- 862.1315 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Bio-Rad Coda Neonatal Galt Assay is an in vitro diagnostic test for the qualitative determination of galactose-1-phosphate uridyl transferase activity in dried blood spot samples. It is used in the diagnosis and treatment of galactosemia, a hereditary disease of galactose metabolism, in infants. The assay uses the Bio-Rad Coda Analyzer and is for in vitro diagnostic use only.
The assay is supplied for use with dried blood spot samples and is a fluorescent procedure for qualitative determination. It has FDA 510K authorization and is classified as a class 2 device with the product code KQP and k number K993536. The device is for single use and is intended for in vitro diagnostic use in a clinical chemistry setting.
Frequently asked questions
What is the Coda Neonatal Galt Assay used for?
The Coda Neonatal Galt Assay is used for the qualitative determination of galactose-1-phosphate uridyl transferase activity in dried blood spot samples to diagnose and treat galactosemia in infants.
Is the Coda Neonatal Galt Assay for single or multiple use?
The Coda Neonatal Galt Assay is intended for single use only in a clinical chemistry setting.
What type of samples does the Coda Neonatal Galt Assay use?
The Coda Neonatal Galt Assay uses dried blood spot samples for the diagnostic test.
What device is required to run the Coda Neonatal Galt Assay?
The Coda Neonatal Galt Assay uses the Bio-Rad Coda Analyzer for the fluorescent procedure.
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: BIO-RAD CODA NEONATAL GALT ASSAY (K993536) — FDA 510 (k) | Innolitics, Bio-rad Coda Neonatal Galt Assay - Beudamed, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K993536 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio-Rad
Sources (1)
- FDA 510(k) K993536 24 fields · synced Sep 21, 2026