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FDA 510(k)

ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT

K-Number: K881932 · 1988-08-01

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1988-08-01
Product CodeGQH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT 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 1988-08-01 under 510(k) number K881932. 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 ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT?

ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT is a medical device that received FDA 510(k) clearance on 1988-08-01. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K881932.

When did ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT receive FDA 510(k) clearance?

ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT received FDA 510(k) clearance on 1988-08-01, under 510(k) number K881932.

Who is the listed applicant for ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT?

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 ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT?

The FDA product code for ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT is GQH.

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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 ASSAYK950625ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)K950568ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)

View all 126 devices →

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.

K982311BARTELS CINAKIT CMV ANTIGENEMIAIntracel Corp.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.K880679BION CMV-G TEST SYSTEMBion Ent., Ltd.

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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