Abx Pentra Bilirubin
FDA 510(k)Class II (US FDA 510(k))
by Horiba Abx
Identifiers
- 510(k) Number
- K060325 FDA 510(k)
- FDA Product Code
- CIG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1110 FDA 510(k)
- Regulation Number
- 862.1110 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Abx Pentra Bilirubin is a device used for the quantitative in vitro diagnostic determination of direct and total bilirubin in human serum and plasma. It operates based on a photometric test using 2,4-dichloroaniline (DCA). The device is classified under the product code CIG and has a regulation number of 862.1110.
The device is supplied as part of the Abx Pentra range, which includes the Abx Pentra Multical, Abx Pentra N Control, and Abx Pentra P. It has been authorized with an FDA 510K clearance. The device is used in clinical chemistry settings for the measurement of bilirubin levels, which are formed during the normal and abnormal destruction of red blood cells.
Frequently asked questions
What is the Abx Pentra Bilirubin used for?
The Abx Pentra Bilirubin is used for the quantitative in vitro diagnostic determination of direct and total bilirubin in human serum and plasma, which is formed during the normal and abnormal destruction of red blood cells.
How is the device supplied?
The device is supplied as part of the Abx Pentra range, which includes the Abx Pentra Multical, Abx Pentra N Control, and Abx Pentra P.
What is the regulatory status of the Abx Pentra Bilirubin?
The device has been authorized with an FDA 510K clearance, indicating it is substantially equivalent to a predicate device.
In what settings is the Abx Pentra Bilirubin used?
The device is used in clinical chemistry settings for the measurement of bilirubin levels.
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: ABX Pentra Bilirubin, Direct - Horiba, ABX Pentra Bilirubin, Direct - Horiba, ABX Pentra 400 Reagents - HORIBA
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060325 | Class II | Active |
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Manufacturer
- Manufacturer
- Horiba Abx
Sources (1)
- FDA 510(k) K060325 24 fields · synced Oct 6, 2026