# K983762: Nuclisens CMV PP67

- Pathway: 510(k) (Traditional)
- Applicant: Organon Teknika Corp.
- Decided: Sep 15, 1999 after 324 days
- Product code: LIN (Antisera, Conjugated Fluorescent, Cytomegalovirus)
- Device class: 2
- Regulation: 21 CFR 866.3175
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CMV Brite™ CMV Antigenemia Detection Test Kit: named in the summary without a submission number

## Indications for use
Then NucliSens® CMV pp67 assay is a nucleic acid amplification-based qualitative assay to be used in conjunction with the Nuclisens® Reader for the detection of human cytomegalovirus (HCMV) pp67 mRNA in EDTA anticoagulated whole blood from adult transplant donors and HIV infected individuals. It is intended as an aid in the diagnosis of active (acute or reactivated) HCMV infection. This product is not intended for use in screening of blood or plasma donors.

Source page: https://510kreport.com/device/K983762
Methodology: https://510kreport.com/methodology