510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NQDClass II

Cardiac C-Reactive Protein, Antigen, Antiserum, And Control

21 CFR 866.5270 / Immunology
FDA source (opens on fda.gov)

NQD is the FDA product code for Cardiac C-Reactive Protein, Antigen, Antiserum, And Control, a class II device type, regulated under 21 CFR 866.5270. FDA's definition for this code reads: "In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments". As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
NQD
Device name
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
FDA definition
In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.
Regulation
21 CFR 866.5270
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
19
Ingested recalls
3

Clearances, product code NQD

By decision year
19 clearances under product code NQD with a decision year between 2004 and 2026, 2006 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code NQD by decision year
YearClearances
20044
20052
20065
20073
20081
20181
20221
20241
20261

Applicants with the most clearances

Product code NQD
Applicants holding the most 510(k) clearances under product code NQD
ApplicantClearances
Siemens Healthcare Diagnostics Inc.11
Roche Diagnostics GmbH3
OLYMPUS Corporation of the Americas2
Ortho-Clinical Diagnostics, Inc.1
Sentinel CH SpA1
Siemens Healthcare Diagnostics Products Limited1

Companies listing this code with FDA

Companies whose registered establishments list this code