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FDA 510(k)

HSV ANTIGEN ELISA KIT

K-Number: K834449 · 1984-05-02

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1984-05-02
Product CodeLGC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HSV ANTIGEN ELISA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1984-05-02 under 510(k) number K834449. The device is classified under product code LGC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HSV ANTIGEN ELISA KIT?

HSV ANTIGEN ELISA KIT is a medical device that received FDA 510(k) clearance on 1984-05-02. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K834449.

When did HSV ANTIGEN ELISA KIT receive FDA 510(k) clearance?

HSV ANTIGEN ELISA KIT received FDA 510(k) clearance on 1984-05-02, under 510(k) number K834449.

Who is the listed applicant for HSV ANTIGEN ELISA KIT?

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

What is the FDA product code for HSV ANTIGEN ELISA KIT?

The FDA product code for HSV ANTIGEN ELISA KIT is LGC.

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Other records listing Ortho Diagnostic Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K951459ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATEK951632ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)K964754ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATEK963902QUANTITATIVE FIBRINOGEN ASSAYK950568ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)K950625ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)

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Related Devices (Code: LGC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K033059HERPES GROUP IGGTrinity Biotech, Inc.K010878MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6Diagnostic Products Corp.K002262DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEMDiamedix Corp.K000238HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900GMrl DiagnosticsK992166THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.K983886POCKIT HSV 2 RAPID TESTDiagnology , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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