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

FDA 510(k)

ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls

K-Number: K213987 · 2023-09-20

ApplicantBiokit, S.A.
Decision Date2023-09-20
Product CodeMXJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls is a medical device manufactured by Biokit, S.A.. It received FDA 510(k) clearance on 2023-09-20 under approval number K213987. The device is classified under product code MXJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls?

ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls is a medical device that received FDA 510(k) clearance on 2023-09-20. It is manufactured by Biokit, S.A.. The 510(k) number is K213987.

When was ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls approved by the FDA?

ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls received FDA 510(k) clearance on 2023-09-20, under approval number K213987.

What company makes ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls?

ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls is manufactured by Biokit, S.A..

What is the FDA product code for ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls?

The FDA product code for ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls is MXJ.

Other Devices by Biokit, S.A.

K152185ARCHITECT SHBG K181333ADVIA Centaur Herpes-1 IgG K181334ADVIA Centaur Herpes-2 IgG K214068Quantia IgE K233606ADVIA Centaur EBV-VCA IgM K233605ADVIA Centaur EBV-EBNA IgG

View all 8 devices →

Related Devices (Code: MXJ)

K162276SeraQuest Herpes Type 1 Specific IgGQuest International, Inc. K181333ADVIA Centaur Herpes-1 IgGBiokit, S.A. K220923Elecsys HSV-1 IgG (08948844160)Roche Diagnostics

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.

↑