FDA product code QJR: Reagents, 2019-Novel Coronavirus Nucleic Acid

QJR is the FDA product code for reagents, 2019-novel coronavirus nucleic acid. It is a Not classified device, reviewed by the Microbiology panel. Devices under QJR reach the market by PMA; FDA lists no cleared 510(k)s for it. FDA has posted 40 recalls for QJR devices, 18 initiated in the last five years.

Definition

Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens.

Classification

Recalls for QJR devices

40 product recalls in 31 recall events; 18 initiated in the last five years and 21 still open. Most recent: 2025-04-28.

HCPCS codes with matching descriptors

Text match between the FDA device name and CMS descriptors, not an official crosswalk:

• U0001 — Cdc 2019 novel coronavirus (2019-ncov) real-time rt-pcr diagnostic panel

Frequently asked questions

What is FDA product code QJR?

QJR is the FDA product code for reagents, 2019-novel coronavirus nucleic acid. It is a Not classified device, reviewed by the Microbiology panel.

What device class is QJR?

Not classified. Typical premarket route: PMA.

Have QJR devices been recalled?

Yes: 40 product recalls across 31 recall events; the most recent began 2025-04-28.

Next steps

• Run an FDA pathway report with predicate devices for product code QJR
• Run a recall and safety report across every QJR manufacturer
• Watch product code QJR for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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