FDA.reportPublic FDA data

IFA: Legionella pneumophila Screening (Mix 1) (IgAGM)

Primary DI
04049016053255
Brand
IFA: Legionella pneumophila Screening (Mix 1) (IgAGM)
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
FI 215b-2005 P
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
04049016053255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049016053255040490160532554049016053255

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

Regulatory Flags#

DUNS number
322209263
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
04049016145646EURORealTime SARS-CoV-2MP 2606-01252020-08-04
04049016145653EURORealTime SARS-CoV-2MP 2606-02252020-08-04
04049016145660EURORealTime SARS-CoV-2MP 2606-04252020-08-04
04049016145691EURORealTime SARS-CoV-2MP 2606-01002020-08-04
04049016145745EURORealTime SARS-CoV-2MP 2606-02002020-08-04
04049016151272FITC-labelled anti-human IgG (primate absorbed)AF 302-0540-R2026-06-10
04049016151289Biotin-labelled anti-human IgGAF 402-0540-1-R2026-06-10
04049016151296FITC-labelled Avidin (biotin affine)AF 402-0540-2-R2026-06-10
04049016151630FITC-labelled anti-human IgG (primate absorbed)AF 302-0546-R2026-06-10
04049016158547Anti-Measles Virus ELISA 2.0 (IgG)EI 2610-9601-2 G2026-05-29
04049016152071TITERPLANE set for the incubation of slides with 10 fieldsZZ 9999-0101-18-R2026-05-11
04049016152118Coded reagent tray for slides with 10 fieldsZZ 9999-0110-12-R2026-05-11
04049016152132Coded reagent tray for slides with 50 fieldsZZ 9999-0150-13-R2026-05-11
04049016152156Coded glass plates for the incubation of slides with 10 fieldsZZ 9999-0510-15-R2026-05-11
04049016152163Coded glass plates for the incubation of slides with 50 fieldsZZ 9999-0550-16-R2026-05-11
04049016155638Incubation tray 44 channels, blackZD 9892-30442026-05-11
04049016151302FITC-labelled anti-human IgA with Evans BlueAF 601-0540-R2026-03-04
04049016151319FITC-labelled anti-human IgG with Evans BlueAF 602-0540-R2026-02-10
04049016151647FITC-labelled anti-human IgG with Evans BlueAF 602-0546-R2026-02-10
04049016026976ANA Screen ELISA (IgG)EA 1590-9601-8 G2016-09-24

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