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SAS Febrile Positive & Negative Control Antiserum

FDA 510(k)

Class II (US FDA 510(k))

510(k) K952145

by Sa Scientific, Inc.

Identifiers

510(k) Number
K952145 FDA 510(k)
FDA Product Code
GSN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3085 FDA 510(k)
Regulation Number
866.3085 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is an antiserum, positive and negative febrile antigen control serum, used as a control in microbiological testing procedures. It is designed to serve as a positive and negative control for febrile antigen testing, ensuring the accuracy and reliability of diagnostic assays.

The device is supplied as a control serum for in vitro diagnostic use and is intended for use in laboratory settings. It is classified as a Class II medical device under FDA regulation number 866.3085, with product code GSN, and received traditional 510(k) clearance (K952145) on July 18, 1995, based on substantial equivalence to a legally marketed predicate device.

Frequently asked questions

What is the SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM used for?

This device is used as a positive and negative control in microbiological testing procedures, specifically for febrile antigen testing, to ensure the accuracy and reliability of diagnostic assays by verifying test performance.

How is the SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM supplied and intended for use?

The device is supplied as a control serum for in vitro diagnostic use and is intended for use in laboratory settings to support the validation of febrile antigen test results.

Is the SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM a single-use or reusable device?

As a control serum intended for in vitro diagnostic use in laboratory settings, it is designed for single-use per test run to prevent cross-contamination and ensure consistent control performance, though specific reuse instructions would depend on laboratory protocols and manufacturer labeling.

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: Sas Febrile Positive & Negative Control Antiserum, K952145 FDA 510(k) - SAS FEBRILE POSITIVE & NEGATIVE CONTROL..., Sas Febrile Positive & Negative Control Antiserum, PDF K952145 Sas Febrile Positive & Negative Control Antiserum

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sa Scientific, Inc.

Sources (1)

  • FDA 510(k) K952145 24 fields · synced Sep 22, 2026