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 ID04053252401121
NIH Device Record Keyd94572f7-1e30-468c-8218-dd742fc91ef4
Commercial Distribution StatusIn Commercial Distribution
Brand NameLight Diagnostics™ Pneumocystis Carinii DFA
Version Model Number3195
Catalog Number3195
Company DUNS829517072
Company NameEMD Millipore Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104053252401121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYFPneumocystis Carinii

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-26

Devices Manufactured by EMD Millipore Corporation

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