Product code NYO— Immunology

ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805

Classification name: Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Total cleared: 4
First cleared: 2006-06-19
Most recent: 2021-09-13

FDA classification definition

“The anti-rna polymerase iii test is a semi-quantitative elisa for the detection of anti-rna polymerase iii antibodies in human serum. The test result is used as an aid in the diagnosis of systemic sclerosis (ssc) in conjunction with the clinical and other laboratory findings. For in-vitro diagnostic use.”
— U.S. Food and Drug Administration, device classification record for product code NYO under 21 CFR 866.5100, via openFDA

Market context for product code NYO

FDA has cleared 4 devices under product code NYO between 2006 and 2021, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20211 clearance
20181 clearance
20071 clearance
20061 clearance

Top applicants under product code NYO

Phadia AB1 clearance
Mbl International Corporation1 clearance
Inova Diagnostics, Inc.1 clearance
Immco Diagnostics, Inc.1 clearance

Recent clearances under product code NYO

K202541 — EliA RNA Pol IIIPhadia AB·2021-09-13
K172078 — ImmuLisa Enhanced RNA POL III Antibody ELISAImmco Diagnostics, Inc.·2018-03-30
K070066 — QUANTA LITE RNA POL III ELISAInova Diagnostics, Inc.·2007-04-11
K060431 — ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805Mbl International Corporation·2006-06-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.