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Light Diagnostics PCP DFA Reagent

Primary DI
04053252730351
Brand
Light Diagnostics PCP DFA Reagent
Company
EMD Millipore Corporation
Model
5195
Catalog number
5195
Device description
Light Diagnostics PCP DFA Reagent
Published
2020-04-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LYFPneumocystis Carinii

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYFPneumocystis CariniiMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992252000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992252000LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965Chemicon Intl., Inc.1999-08-10LYF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053252730351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053252730351040532527303514053252730351

GMDN Terms#

Term, Definition table
TermDefinition
Pneumocystis jirovecii antigen IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Pneumocystis jirovecii in a clinical specimen, using a fluorescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
829517072
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04053252732638Light Diagnostics VZV DFA Reagent509450942020-04-03
04053252282133Light Diagnostics™ Human Metapneumovirus Direct Immunofluorescence Assay312431242016-09-23
04053252371745Light Diagnostics™ Simulfluor® HSV / VZV DFA 329532952016-09-09
04053252401121Light Diagnostics™ Pneumocystis Carinii DFA 319531952016-09-26
04061839405141MIDAS® III-Plus Automated Stainer64000H-942022-06-28
04053252270239Light Diagnostics ™ SimulFluor® Flu A / Flu B Reagent5250-5ML5250-5ML2022-12-01
04053252282393Light Diagnostics ™ Respiratory Syncytial Virus (RSV) Control Slides5012-55012-52022-12-01
04053252286575Light Diagnostics ™ Respiratory Viral Control Slides (8 Well)5071-105071-102022-12-01
04053252325519Light Diagnostics ™ Parainfluenza 1, 2, 3 Control Slides5011-55011-52022-12-01
04053252373435Light Diagnostics ™ Influenza A & B Control Slides5010-55010-52022-12-01
04053252473166Light Diagnostics ™ SimulFluor® Respiratory Screen Kit3296-2ML3296-2ML2022-12-01
04053252507007Light Diagnostics ™ Respiratory Screen DFA Reagent5307-2ML5307-2ML2022-12-01
04053252508295Light Diagnostics ™ Adenovirus Control Slides5009-55009-52022-12-01
04053252670114Light Diagnostics ™ Parainfluenza 4 Control Slides (5 Pack)5098-55098-52022-12-01
04061839705098Light Diagnostics ™ SimulFluor® Respiratory Screen Reagent5296-2ML5296-2ML2022-12-01
04053252280238Light Diagnostics ™ Parainfluenza 3 FITC-Labeled Monoclonal Antibody502150212022-11-30
04053252284311Light Diagnostics ™ Normal Mouse Antibody501450142022-11-30
04053252320439Light Diagnostics ™ Influenza A FITC-Labeled Monoclonal Antibody501750172022-11-30
04053252332555Light Diagnostics ™ SimulFluor® RSV/Para 3 Reagent524052402022-11-30
04053252362224Light Diagnostics ™ Parainfluenza 2 FITC-Labeled Monoclonal Antibody502050202022-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04053252401121Light Diagnostics™ Pneumocystis Carinii DFA EMD Millipore CorporationLYF2016-09-26
00840733101106MERIFLUOR PneumocystisMERIDIAN BIOSCIENCE, INC.LYF2016-09-23
00847865001502MONOFLUOBio-RAD Laboratories, Inc.LYF2016-09-12
00847865001519MONOFLUOBio-RAD Laboratories, Inc.LYF2016-09-12