West Nile Detect Igm Elisa

Q: What is the product code of K041817?

The FDA product code is NOP – Elisa, Antibody, West Nile Virus, a Class II (moderate risk) device regulated under 21 CFR 866.3940.

FDA 510(k) K041817 · Inbios Intl., Inc.

Substantially Equivalent

510(k) numberK041817

Submission

Device name: West Nile Detect Igm Elisa
Applicant: Inbios Intl., Inc.
Seattle, WA, US
Received: July 6, 2004
Decision date: November 19, 2004
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: NOP – Elisa, Antibody, West Nile Virus
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.3940
Specialty: Microbiology

The West Nile Virus ELISA is intended for the detection of IgG and IgM antibodies to West Nile Virus. Specimens may be serum or cerebral spinal fluid from symptomatic patients.

Other 510(k)s with product code NOP

510(k)	Device	Applicant	Decision
K153308	EUROIMMUN Anti-West Nile Virus ELISA (IgM)NOP · Traditional	Euroimmun Us, Inc.	08/12/2016SE
K153303	EUROIMMUN Anti-West Nile Virus ELISA (IgG)NOP · Traditional	Euroimmun Us, Inc.	08/10/2016SE
K052519	Spectral West Nile Virus Igm Status TestNOP · Traditional	Spectral Diagnostics, Inc.	11/30/2006SE
K041068	West Nile Virus Igg Indirect ElisaNOP · Traditional	Panbio Limited	10/20/2004SE
K041231	West Nile Virus Igm Capture Elisa, Model E-WNV02MNOP · Traditional	Panbio Limited	08/10/2004SE
K040854	West Nile Virus Igm Capture ElisaNOP · Traditional	Focus Technologies, Inc.	06/30/2004SE
K031953	West Nile Virus Elisa Igg, Model EL0300GNOP · Traditional	Focus Technologies, Inc.	10/22/2003SE
K031952	West Nile Virus Igm Capture Elisa, Model EL0300MNOP · Traditional	Focus Technologies, Inc.	10/22/2003SE

More from Focus Technologies, Inc.

510(k)	Device	Decision
K023483	Kalazar DetectLOO · Traditional	05/06/2003SE
K001092	Generic Blood Glucose Test StripCGA · Traditional	07/26/2000SE
K992695	Insure Pro TestJHI · Traditional	10/18/1999SE
K991515	Insure Pregnancy TestDHA · Traditional	05/28/1999SE

Questions and answers

When was West Nile Detect Igm Elisa cleared by the FDA?

West Nile Detect Igm Elisa (K041817) received a 510(k) decision of Substantially Equivalent on November 19, 2004, 136 days after the submission was received.

What is the product code of K041817?

The FDA product code is NOP – Elisa, Antibody, West Nile Virus, a Class II (moderate risk) device regulated under 21 CFR 866.3940.