Light Diagnostics™ Pneumocystis Carinii DFA

Basic Information

• Brand Name: Light Diagnostics™ Pneumocystis Carinii DFA
• Primary DI: 04053252401121
• Version / Model: 3195
• Catalog Number: 3195
• Company Name: EMD Millipore Corporation
• Labeler DUNS: 829517072
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: d94572f7-1e30-468c-8218-dd742fc91ef4

Device Description

PCP DFA Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYF	Pneumocystis Carinii	Microbiology	866.3780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52096	Pneumocystis jirovecii antigen IVD, kit, direct fluorescent test (DFT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from the fungus Pneumocystis jirovecii (formerly known as P. carinii) in a clinical specimen, using a direct fluorescent test (DFT).	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04053252401121	GS1

Premarket Submissions

Submission Number	Supplement Number
K992252	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius