JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136

Nucleic Acid Amplification, Novel Influenza A Virus, A/h5 (asian Lineage) Rna

U.S. ARMY MEDICAL MATERIAL DEVELOPMENT COMMAND

The following data is part of a premarket notification filed by U.s. Army Medical Material Development Command with the FDA for Jbaids Influenza A/h5 Detection Kit, Model Jrpd-asy-0136.

Pre-market Notification Details

• Device ID: K100287
• 510k Number: K100287
• Device Name: JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136
• Classification: Nucleic Acid Amplification, Novel Influenza A Virus, A/h5 (asian Lineage) Rna
• Applicant: U.S. ARMY MEDICAL MATERIAL DEVELOPMENT COMMAND 1430 VETERANS DRIVE Fort Detrick, MD
• Contact: Robert E Miller
• Correspondent: Robert E Miller; U.S. ARMY MEDICAL MATERIAL DEVELOPMENT COMMAND 1430 VETERANS DRIVE Fort Detrick, MD
• Product Code: NXD
• CFR Regulation Number: 866.3332 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-01-29
• Decision Date: 2010-07-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00851458005082	K100287	000