FDA.reportPublic FDA data

Legionella IFA

Primary DI
20816101020045
Brand
Legionella IFA
Company
DIASORIN MOLECULAR LLC
Model
IF0950
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LHLReagents, Antibody, Legionella, Direct & Indirect Fluorescent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHLReagents, Antibody, Legionella, Direct & Indirect FluorescentMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20816101020045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081610102004520816101020045

GMDN Terms#

Term, Definition table
TermDefinition
Legionella pneumophila total antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to one or multiple serogroups of Legionella pneumophila in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Legionella pneumophila, the bacteria associated with Legionnaires' disease.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
562-240-6500DxTs@focusdx.com

Regulatory Flags#

DUNS number
080271715
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20816101020243Rickettsia IFA IgGIF0100GIF0100G2026-03-13
20816101020250Rickettsia IFA IgMIF0100MIF0100M2026-03-13
20816101020342Q Fever IFA IgGIF0200GIF0200G2026-03-13
20816101020359Q Fever IFA IgMIF0200MIF0200M2026-03-13
20816101020397Arbovirus IFA IgGIF0300GIF0300G2026-03-13
20816101020403Arbovirus IFA IgMIF0300MIF0300M2026-03-13
20816101025538Simplexa™ Flu A/B & RSVMOL2600MOL26002016-09-22
20816101025507Simplexa™ HSV 1 & 2 DirectMOL2150MOL21502016-09-22
20816101025514Simplexa™ HSV 1 & 2 Positive Control PackMOL2160MOL21602016-09-22
10816101025142LIAISON NES® InstrumentNES1001NES10012026-01-22
10816101025159LIAISON NES® Instrument (Refurbished)NES1001RNES1001R2026-01-22
20816101029031LIAISON NES® FLU A/B, RSV & COVID-19NES4450NES44502026-01-22
20816101029048LIAISON NES® FLU A/B, RSV & COVID-19 Control Swab KitNES4460NES44602026-01-22
20816101027358Simplexa COVID-19 / Flu A/B & RSV DirectMOL4450MOL44502026-01-14
20816101027365Simplexa COVID-19 / Flu A/B & RSV Positive Control PackMOL4460MOL44602026-01-14
10816101020772R. rickettsii Substrate SlideIF0102IF01022025-12-16
10816101027375Blastomyces Primer PairMOL9206MOL92062025-12-16
20816101027136Simplexa COVID-19 Positive Control GEN II Pack MOL4165MOL41652025-09-17
10816101025005Integrated Cyler (110V)MOL1001MOL10012016-09-24
10816101025012Integrated Cyler (110V) Pre-OwnedMOL1001-PMOL1001-P2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10628429001674Legionella pneumophila Serogroup 2 DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001681Legionella pneumophila Serogroup 3 DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001698Legionella pneumophila Serogroup 4 DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001704Legionella pneumophila Serogroup 5 DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001711Legionella pneumophila Serogroup 6 DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001728Legionella micdadei DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001735Phosphate Buffered Saline (pH 7.6)PRO-LAB, INCORPORATEDLHL2022-12-25
10628429001759Legionella DFA Negative ControlPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001766Prolex Legionella pneumophila Serogroup 2 Latex ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001773Prolex Legionella pneumophila Serogroup 3 Latex ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001780Prolex Legionella pneumophila Serogroup 4 Latex ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001797Prolex Legionella pneumophila Serogroup 5 Latex ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001803Prolex Legionella pneumophila Serogroup 6 Latex ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001810Prolex Legionella micdadeiPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001827Prolex Legionella pneumophila Negative Control Latex ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001834Legionella pneumophila Serogroup 1 DFA Kit (50 tests)PRO-LAB, INCORPORATEDLHL2022-12-25
10628429001841Legionella pneumophila Serogroups 1-14 DFA Kit (50 tests)PRO-LAB, INCORPORATEDLHL2022-12-25
10628429001858Legionella pneumophila Serogroup 7 DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001865Legionella pneumophila Serogroup 8 DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001872Legionella pneumophila Serogroup 9 DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001889Legionella pneumophila Serogroup 10 DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001896Legionella pneumophila Serogroup 11 DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001902Legionella pneumophila Serogroup 12 DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001919Legionella pneumophila Serogroup 13 DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001926Legionella pneumophila Serogroup 14 DFA ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429001933Legionella pneumophila Positive Control Serogroups 1-14PRO-LAB, INCORPORATEDLHL2022-12-25
10628429002015Prolex Legionella pneumophila Serogroup 7 Latex ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429002022Prolex Legionella pneumophila Serogroup 8 Latex ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429002039Prolex Legionella pneumophila Serogroup 9 Latex ReagentPRO-LAB, INCORPORATEDLHL2022-12-25
10628429002046Prolex Legionella pneumophila Serogroup 10 Latex ReagentPRO-LAB, INCORPORATEDLHL2022-12-25