Dna-reagents, Neisseria

Device Code: 3455

Product Code(s): LSL

Device Classification Information

• Device Type ID: 3455
• Device Name: Dna-reagents, Neisseria
• Regulation Description: Neisseria Spp. Direct Serological Test Reagents.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 866.3390 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: LSL
• GMP Exempt: No
• Summary MR: Ineligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-260 CLSI MM03-3rd Edition (Replaces MM03-A2)
  Molecular Diagnostic Methods For Infectious Diseases; Approved Guideline

Total Product Life Cycle

• Device Type ID: 3455
• Device: Dna-reagents, Neisseria
• Product Code: LSL
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Neisseria Spp. Direct Serological Test Reagents.
• CFR Regulation Number: 866.3390 [🔎]

Premarket Reviews
Manufacturer	Decision
ABBOTT LABORATORIES
	SUBSTANTIALLY EQUIVALENT	1
BD
	SUBSTANTIALLY EQUIVALENT	1
BECTON, DICKINSON & CO.
	SUBSTANTIALLY EQUIVALENT	1
CEPHEID
	SUBSTANTIALLY EQUIVALENT	1
HOLOGIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS CORP.
	SUBSTANTIALLY EQUIVALENT	3
ROCHE DIAGNOSTICS OPERATIONS INC.
	SUBSTANTIALLY EQUIVALENT	3

Device Problems
Output Problem	2
Device Handling Problem	1
High Readings	1
Total Device Problems	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Cepheid	II	Feb-12-2018
2	Cepheid	III	Aug-20-2015

TPLC Last Update: 2019-04-02 20:30:26