CFDA intends to adjust three categories of in vitro diagnostic reagents: 287 products are not medical devices

June 01, 2023

On September 21, the General Administration of Food and Drug Administration issued the "Letter on the Approval of the Classification of Three Types of In Vitro Diagnostic Reagents for Allergens" (Food and Drug Administration Control Letter [2016] No. 63), on allergens, flow cytometry The classification and adjustment opinions of the supporting and immunohistochemical in vitro diagnostic reagent products are open for public comment. The deadline for comments is October 31, 2016. The specific classification is as follows:

I. Allergens in vitro diagnostic reagents

Reagents related to allergies (allergens), including total IgE detection reagents, specific IgE antibody detection reagents, are managed as a third type of medical device.

Note: In the list of classification and attribute suggestion adjustments given, 573 products are specifically included.

CFDA intends to adjust three categories of in vitro diagnostic reagents: 287 products are not medical devices

Second, in vitro diagnostic reagents for flow cytometry

(1) Products managed as a third type of in vitro diagnostic reagents, including:

1. An agent for the diagnosis of leukemia and lymphoma;

2. For multicolor lymphocyte subset analysis reagents;

3. Reagents related to the detection of hereditary diseases;

4. Reagents associated with the detection of tumor markers;

5. Reagents associated with tissue typing detection;

6. Reagents related to target detection of therapeutic drugs;

Note: In the given classification and attribute suggestion adjustment table, it specifically includes 126 products.

(2) Products managed as the first type of in vitro diagnostic reagents, including:

1. Flow cytometry supporting sample processing reagents;

2. Flow cytometry supporting running reagents;

3. The flow cytometer is equipped with calibration reagents.

Note: In the given classification and attribute suggestion adjustment table, specifically include 30 products.

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