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OVAClass II

Complete Gene Expression Profiling Accessory Reagents

21 CFR 862.2570 / Clinical Chemistry
FDA source (opens on fda.gov)

OVA is the FDA product code for Complete Gene Expression Profiling Accessory Reagents, a class II device type, regulated under 21 CFR 862.2570. FDA's definition for this code reads: "Complete gene expression profiling accessory reagent kits include all components necessary to perform transcript synthesis, fluorescent labeling, and detection and are intended to carry out all processing steps for separately cleared gene expression microarray assays which specify their use. They are designed and...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OVA
Device name
Complete Gene Expression Profiling Accessory Reagents
FDA definition
Complete gene expression profiling accessory reagent kits include all components necessary to perform transcript synthesis, fluorescent labeling, and detection and are intended to carry out all processing steps for separately cleared gene expression microarray assays which specify their use. They are designed and optimized for preparation of labeled complementary RNA (cRNA) target using total RNA isolated from specific clinical tissue specimens for hybridization to and measurement of fluorescently-labeled cRNA targets using a specified and cleared microarray instrumentation system. They may also include specified exogenous controls intended to monitor amplification and labeling processes.
Regulation
21 CFR 862.2570
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code OVA

By decision year
1 clearance under product code OVA with a decision year between 2011 and 2011, 2011 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OVA by decision year
YearClearances
20111

Applicants with the most clearances

Product code OVA
Applicants holding the most 510(k) clearances under product code OVA
ApplicantClearances
Affymetrix Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code OVA.