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FDA 510(k)

Diazyme DZ-Lite Total beta-hCG Test System

K-Number: K163418 · 2017-08-18

ApplicantDiazyme Laboratories
Decision Date2017-08-18
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Diazyme DZ-Lite Total beta-hCG Test System is a medical device manufactured by Diazyme Laboratories. It received FDA 510(k) clearance on 2017-08-18 under approval number K163418. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Diazyme DZ-Lite Total beta-hCG Test System?

Diazyme DZ-Lite Total beta-hCG Test System is a medical device that received FDA 510(k) clearance on 2017-08-18. It is manufactured by Diazyme Laboratories. The 510(k) number is K163418.

When was Diazyme DZ-Lite Total beta-hCG Test System approved by the FDA?

Diazyme DZ-Lite Total beta-hCG Test System received FDA 510(k) clearance on 2017-08-18, under approval number K163418.

What company makes Diazyme DZ-Lite Total beta-hCG Test System?

Diazyme DZ-Lite Total beta-hCG Test System is manufactured by Diazyme Laboratories.

What is the FDA product code for Diazyme DZ-Lite Total beta-hCG Test System?

The FDA product code for Diazyme DZ-Lite Total beta-hCG Test System is DHA.

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

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Related Devices (Code: DHA)

K170317Alinity i Total ß-hCG Reagent Kit, Alinity i SystemAbbott Laboratories K192790Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc. K192547MAGLUMI 2000 HCG/ß-HCGShenzhen New Industries Biomedical Engineering Co., Ltd. K212221Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay AnalyzerDiazyme Laboratories, Inc. K203227Elecsys HCG STATRoche Diagnostics K200210ADVIA Centaur® Total hCG assaySiemens Healthcare Diagnostics, Inc.

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.

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