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Rapet CRP

FDA 510(k)

Class II (US FDA 510(k))

510(k) K974429

by Stanbio Laboratory

Identifiers

510(k) Number
K974429 FDA 510(k)
FDA Product Code
DCN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5270 FDA 510(k)
Regulation Number
866.5270 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Rapet CRP is a Test System for C-Reactive Protein (CRP), designed for the qualitative and semiquantitative detection of CRP in human serum. Classified under the nomenclature for immunochemistry assays, it functions as a rapid slide-based diagnostic tool to assess tissue injury and inflammatory responses.

This device is supplied as a 100-test kit (M-833) or single-test units, requiring human serum samples for analysis. It operates under CLIA Moderate Complexity standards and must be stored under refrigeration. The test involves visual reading on a 6-well plastic slide, with included reagents such as CRP latex reagent, positive/negative controls, and glycine-saline buffer concentrate. No regulatory status beyond the provided FDA 510K clearance is stated in the data.

Frequently asked questions

What types of samples can the Rapet CRP test system analyze, and how is it intended to be used in a clinical setting?

The Rapet CRP test system is designed specifically for human serum samples and functions as a rapid slide-based diagnostic tool for the qualitative and semiquantitative detection of C-Reactive Protein (CRP). It is intended for assessing tissue injury and inflammatory responses in clinical settings operating under CLIA Moderate Complexity standards. The test involves visual reading on a 6-well plastic slide, making it suitable for point-of-care or laboratory use where CRP levels need to be evaluated quickly.

How is the Rapet CRP test system supplied, and what components are included in each kit?

The Rapet CRP test system is supplied as either a 100-test kit (M-833) or as single-test units. Each kit or unit includes essential reagents such as CRP latex reagent, positive and negative controls, and glycine-saline buffer concentrate. These components are necessary for performing the test on the provided 6-well plastic slide.

Is the Rapet CRP test system intended for single-use or can it be reused? What storage conditions are required?

The Rapet CRP test system is designed for single-use per test or per kit, depending on the configuration (single-test units or 100-test kits). The test system itself, including the slide and reagents, is not reusable. The device must be stored under refrigeration to maintain its integrity and performance, as specified in the manufacturer’s instructions.

Are there different sizes or models of the Rapet CRP test system, and if so, how do they differ?

The Rapet CRP test system is available in two primary configurations: a 100-test kit (catalog number M-833) and single-test units. While both serve the same purpose of detecting CRP in human serum, the primary difference lies in the quantity of tests provided per package. The single-test units are ideal for occasional use, whereas the 100-test kit is better suited for higher-volume testing environments.

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: Stanbio Laboratory Rapid Test Kit RaPET® CRP Immunochemistry / Specific ..., Stanbio Laboratory Rapid Test Kit RaPET® CRP Immunochemistry / Specific ..., Stanbio Laboratory RaPETÂ CRP 1130-100 100 Tests Visual Read CRP Test

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Stanbio Laboratory

Sources (1)

  • FDA 510(k) K974429 24 fields · synced Sep 19, 2026