FDA 510(k)

cobas® liat CT/NG nucleic acid test

K-번호: K240217 · 2025-01-17

결정일2025-01-17

제품 코드QEP

자문 위원회MI

결정Substantially Equivalent

기기 요약

cobas® liat CT/NG nucleic acid test is the device name listed in this FDA 510(k) record. The listed applicant is Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2025-01-17 under 510(k) number K240217. The device is classified under product code QEP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the cobas® liat CT/NG nucleic acid test?

cobas® liat CT/NG nucleic acid test is a medical device that received FDA 510(k) clearance on 2025-01-17. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K240217.

When did cobas® liat CT/NG nucleic acid test receive FDA 510(k) clearance?

cobas® liat CT/NG nucleic acid test received FDA 510(k) clearance on 2025-01-17, under 510(k) number K240217.

Who is the listed applicant for cobas® liat CT/NG nucleic acid test?

The FDA 510(k) record lists Roche Molecular Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for cobas® liat CT/NG nucleic acid test?

The FDA product code for cobas® liat CT/NG nucleic acid test is QEP.

Roche Molecular Systems, Inc.를 신청인으로 등재한 기타 기록

K260045cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190)K260047cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)K260021cobas® BV/CV K260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems K253756cobas liat CT/NG nucleic acid test K253759cobas liat CT/NG/MG nucleic acid test

36개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.