Sofia Lyme FIA；Sofia 2 螺旋菌 FIA
K号: K254295 · 2026-07-10
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决定日期2026-07-10
产品代码LSR
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决定实质等同
器械摘要
Sofia Lyme FIA; Sofia 2 Campylobacter FIA is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Clinical Diagnostics, Inc. (QuidelOrtho). It received FDA 510(k) clearance on 2026-07-10 under 510(k) number K254295. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Sofia Lyme FIA; Sofia 2 Campylobacter FIA?
Sofia Lyme FIA; Sofia 2 Campylobacter FIA is a medical device that received FDA 510(k) clearance on 2026-07-10. The listed applicant is Ortho-Clinical Diagnostics, Inc. (QuidelOrtho). The 510(k) number is K254295.
When did Sofia Lyme FIA; Sofia 2 Campylobacter FIA receive FDA 510(k) clearance?
Sofia Lyme FIA; Sofia 2 Campylobacter FIA received FDA 510(k) clearance on 2026-07-10, under 510(k) number K254295.
Who is the listed applicant for Sofia Lyme FIA; Sofia 2 Campylobacter FIA?
FDA 510(k)记录中列出Ortho-Clinical Diagnostics, Inc.（QuidelOrtho）为申请人。这本身并不足以确立该设备制造商的身份。
What is the FDA product code for Sofia Lyme FIA; Sofia 2 Campylobacter FIA?
The FDA product code for Sofia Lyme FIA; Sofia 2 Campylobacter FIA is LSR.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：LSR）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K252627Lyme-ID IgG 测试；Bio-ID800Inanovate, Inc.K242872iDart Lyme IgM ImmunoBlot KitId-Fish Technology, Inc.K233367iDart莱姆病IgG免疫印迹试剂盒Id-Fish Technology, Inc.K230863宙斯索利纳斯伯氏螺旋体VlsE1/pepC10 IgG/IgM检测系统；宙斯索利纳斯伯氏螺旋体VlsE1/pepC10 IgG/IgM对照试剂盒Zeus ScientificK220016Viramed Borrela 全合一 ViraChip 检测试剂盒Viramed Biotech AGK203292Gold Standard Diagnostics 摩氏菌 IgG/IgM ELISA 测试试剂盒Gold Standard Diagnostics
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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