# K040241: N-Geneous Wide Range CRP Reagent and Calibrator Set

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Corp.
- Decided: Jun 25, 2004 after 143 days
- Product code: DCK (C-Reactive Protein, Antigen, Antiserum, And Control)
- Device class: 2
- Regulation: 21 CFR 866.5270
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Dade Behring N High Sensitive CRP method: named in the summary without a submission number
- (no number) Dade Behring N Rheumatology Standard SL: named in the summary without a submission number

## Most influential descendants
- K052591: Nanopia Wide Range C-Reactive Protein (CRP) Reagent Kit (2006), 0 descendants of its own

## Indications for use
Reagents: For the quantitative measurement of C-Reactive Protein (CRP) concentration in serum or plasma. For In Vitro Diagnostic Use Calibrator: For the calibration of the N-geneousTM Wide Range CRP assay. For In Vitro Diagnostic Use

Source page: https://510kreport.com/device/K040241
Methodology: https://510kreport.com/methodology