Light Diagnostics™ Pneumocystis Carinii DFA 3195

GUDID 04053252401121

PCP DFA Kit

EMD Millipore Corporation

Pneumocystis jirovecii antigen IVD, kit, direct fluorescent test (DFT)

• Primary Device ID: 04053252401121
• NIH Device Record Key: d94572f7-1e30-468c-8218-dd742fc91ef4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Light Diagnostics™ Pneumocystis Carinii DFA
• Version Model Number: 3195
• Catalog Number: 3195
• Company DUNS: 829517072
• Company Name: EMD Millipore Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053252401121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992252

FDA Product Code

• LYF: Pneumocystis Carinii

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-26

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