Dna Probe, Nucleic Acid Amplification, Chlamydia

Device Code: 3497

Product Code(s): MKZ

Device Classification Information

• Device Type ID: 3497
• Device Name: Dna Probe, Nucleic Acid Amplification, Chlamydia
• Regulation Description: Chlamydia Serological 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: 866.3120 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: MKZ
• GMP Exempt: No
• Summary MR: Ineligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

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: 3497
• Device: Dna Probe, Nucleic Acid Amplification, Chlamydia
• Product Code: MKZ
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Chlamydia Serological Reagents.
• CFR Regulation Number: 866.3120 [🔎]

Premarket Reviews
Manufacturer	Decision
BD
	SUBSTANTIALLY EQUIVALENT	1
BECTON, DICKINSON & CO.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
False Negative Result	1
False Positive Result	1
Use Of Device Problem	1
Total Device Problems	3

TPLC Last Update: 2019-04-02 20:31:12