Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CYTOMEGALOVIRUS IGG EIA KIT

K-Number: K880433 · 1989-03-27

ApplicantDe Ferris Laboratories, Inc.
Decision Date1989-03-27
Product CodeLFZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CYTOMEGALOVIRUS IGG EIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is De Ferris Laboratories, Inc.. It received FDA 510(k) clearance on 1989-03-27 under 510(k) number K880433. The device is classified under product code LFZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYTOMEGALOVIRUS IGG EIA KIT?

CYTOMEGALOVIRUS IGG EIA KIT is a medical device that received FDA 510(k) clearance on 1989-03-27. The listed applicant is De Ferris Laboratories, Inc.. The 510(k) number is K880433.

When did CYTOMEGALOVIRUS IGG EIA KIT receive FDA 510(k) clearance?

CYTOMEGALOVIRUS IGG EIA KIT received FDA 510(k) clearance on 1989-03-27, under 510(k) number K880433.

Who is the listed applicant for CYTOMEGALOVIRUS IGG EIA KIT?

The FDA 510(k) record lists De Ferris Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CYTOMEGALOVIRUS IGG EIA KIT?

The FDA product code for CYTOMEGALOVIRUS IGG EIA KIT is LFZ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing De Ferris Laboratories, 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.

K875258TOXOPLASMA GONDII IGG ELISA KIT

Related Devices (Code: LFZ)

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.

K220949Architect CMV IgGAbbott LaboratoriesK220911Elecsys CMV IgGRoche DiagnosticsK181213ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality ControlSiemens Healthcare Diagnostics, Inc.K163569Elecsys CMV IgMRoche DiagnosticsK162969LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetDiaSorin, Inc.K040290DIASORIN LIAISON CMV IGM/IGGDiasorin S.P.A

Official Source

View on FDA Database →

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

↑