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FDA 510(k)

BARTELS CINAKIT CMV ANTIGENEMIA

K-Number: K982311 · 1998-12-14

ApplicantIntracel Corp.
Decision Date1998-12-14
Product CodeGQH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BARTELS CINAKIT CMV ANTIGENEMIA is the device name listed in this FDA 510(k) record. The listed applicant is Intracel Corp.. It received FDA 510(k) clearance on 1998-12-14 under 510(k) number K982311. The device is classified under product code GQH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARTELS CINAKIT CMV ANTIGENEMIA?

BARTELS CINAKIT CMV ANTIGENEMIA is a medical device that received FDA 510(k) clearance on 1998-12-14. The listed applicant is Intracel Corp.. The 510(k) number is K982311.

When did BARTELS CINAKIT CMV ANTIGENEMIA receive FDA 510(k) clearance?

BARTELS CINAKIT CMV ANTIGENEMIA received FDA 510(k) clearance on 1998-12-14, under 510(k) number K982311.

Who is the listed applicant for BARTELS CINAKIT CMV ANTIGENEMIA?

The FDA 510(k) record lists Intracel Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARTELS CINAKIT CMV ANTIGENEMIA?

The FDA product code for BARTELS CINAKIT CMV ANTIGENEMIA is GQH.

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Other records listing Intracel Corp. 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.

K003204BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KITK991074BARTELS LEGIONELLA URINARY ANTIGEN ELISA TESTK990664PRIMA SYSTEM - OLD, BARTELS ELISA - NEWK933878ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT

Related Devices (Code: GQH)

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.

K964875CMV ANTIGEN CONTROL SLIDESViral Antigens, Inc.K935809CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAYLight DiagnosticsK882835INDIRECT FLUORESCENT ASSAY FOR (HCMV)Stellar Bio Systems, Inc.K882024FITC MURINE MONOCLONAL ANTI-CMV IGGWhittaker Bioproducts, Inc.K881932ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENTOrtho Diagnostic Systems, Inc.K880679BION CMV-G TEST SYSTEMBion Ent., 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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