FDA.report

IFA: Legionella Mosaic 4 (IgG)

Primary DI
04049016089537
Brand
IFA: Legionella Mosaic 4 (IgG)
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
FI 2150-2005-4 G
Published
2016-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
LHLReagents, Antibody, Legionella, Direct & Indirect Fluorescent

Product Code Classifications

CodeDeviceSpecialtyClass
LHLReagents, Antibody, Legionella, Direct & Indirect FluorescentMicrobiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049016089537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049016089537040490160895374049016089537

GMDN Terms

TermDefinition
Multiple Legionella species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to multiple species of Legionella bacteria in a clinical specimen, using a fluorescent immunoassay method. Legionella species intended to be detected may include Legionella pneumophila, L. longbeachae, L. jordanis, L. bozemanii, L. gormanii, L. micdadei, and L. dumoffii which are associated with pneumonia-like respiratory infection and Legionnaires' disease.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
322209263
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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
04049016151340FITC-labelled anti-human IgG with propidium iodide for EUROPatternAF 702-0540-2-R2026-01-29
04049016151654FITC-labelled anti-human IgG with propidium iodide for EUROPatternAF 702-0546-2-R2026-01-29
04049016152057EUROArray wash buffer setZM 0123-0101-R2022-12-08
04049016151814ELISA wash buffer 10x conc.ZE 1120-101002026-01-13
04049016116110Anti-Echinococcus EUROLINE WB (IgG)DY 2321-1601-1 G2022-12-08
04049016151951Tween 20 (IFA)ZF 1110-0420-R2026-01-06
04049016151968Tween 20 (IFA)ZF 1110-1002-R2026-01-06
04049016092599Anti-Glutamate receptor (type NMDA) IFAFB 112d-1005-512025-12-19
04049016092605Anti-Glutamate receptor (type NMDA) IFAFB 112d-1010-512025-12-19
04049016126034EUROArrayScanYG 0621-01012025-12-19
04049016152101Reagent tray for incubation of slidesZZ 9999-0105-R2025-11-27
04049016152125Reagent tray for incubation of slidesZZ 9999-0110-R2025-11-27
04049016139232Free Triiodothyronine (FT3) ELISAEQ 1016-96012022-12-08
04049016151982Mounting medium (IIFT)ZF 1200-0430-R2025-07-03
04049016152002Mounting medium (IIFT)ZF 1200-1003-R2025-07-03
04049016151791ELISA sample bufferZE 1100-101002025-07-02
04049016151838ELISA chromogen/substrate solutionZE 1200-10122025-07-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10628429001742Legionella DFA Mounting MediumPRO-LAB, INCORPORATEDLHL2022-12-25
15060392378349Mast Assure AntiseraMAST GROUP LIMITEDLHL2018-11-19
00816576023141NAHARDY DIAGNOSTICSLHL2017-08-10
00816576023158NAHARDY DIAGNOSTICSLHL2017-08-10
00816576023172NAHARDY DIAGNOSTICSLHL2017-08-10
00816576023127NAHARDY DIAGNOSTICSLHL2017-06-08
00816576023134NAHARDY DIAGNOSTICSLHL2017-06-08
04049016085164IFA Mosaic: Legionella non-pneumophila (IgAGM)EUROIMMUN Medizinische Labordiagnostika AGLHL2016-10-10
04049016089513IFA: Legionella Mosaic 4 (IgG)EUROIMMUN Medizinische Labordiagnostika AGLHL2016-10-10
04049016089520IFA: Legionella Mosaic 4 (IgG)EUROIMMUN Medizinische Labordiagnostika AGLHL2016-10-10
04049016105923IFA: Legionella Mosaic 4 (IgAGM)EUROIMMUN Medizinische Labordiagnostika AGLHL2016-10-10
04049016105930IFA: Legionella Mosaic 4 (IgAGM)EUROIMMUN Medizinische Labordiagnostika AGLHL2016-10-10
04049016105947IFA: Legionella Mosaic 4 (IgAGM)EUROIMMUN Medizinische Labordiagnostika AGLHL2016-10-10
04049016052876IFA: BIOCHIP Sequence Legionella pneumophila (IgAGEUROIMMUN Medizinische Labordiagnostika AGLHL2016-09-24
04049016052890IFA: BIOCHIP Sequence Legionella pneumophila (IgAGEUROIMMUN Medizinische Labordiagnostika AGLHL2016-09-24
04049016052906IFA: BIOCHIP Sequence Legionella pneumophila (IgAGEUROIMMUN Medizinische Labordiagnostika AGLHL2016-09-24
04049016053149Legionella pneumophila Screening (Mix 1/2/3/4) IFAEUROIMMUN Medizinische Labordiagnostika AGLHL2016-09-24
04049016053156Legionella pneumophila Screening (Mix 1/2/3/4) IFAEUROIMMUN Medizinische Labordiagnostika AGLHL2016-09-24
04049016053163Legionella pneumophila Screening (Mix 1/2/3/4) IFAEUROIMMUN Medizinische Labordiagnostika AGLHL2016-09-24
04049016053170Legionella pneumophila Screening (Mix 1/2/3/4) IFAEUROIMMUN Medizinische Labordiagnostika AGLHL2016-09-24
04049016053224IFA: Legionella pneumophila Screening (Mix 1) (IgAEUROIMMUN Medizinische Labordiagnostika AGLHL2016-09-24
04049016053231IFA: Legionella pneumophila Screening (Mix 1) (IgAEUROIMMUN Medizinische Labordiagnostika AGLHL2016-09-24
04049016053248IFA: Legionella pneumophila Screening (Mix 1) (IgAEUROIMMUN Medizinische Labordiagnostika AGLHL2016-09-24
04049016053255IFA: Legionella pneumophila Screening (Mix 1) (IgAEUROIMMUN Medizinische Labordiagnostika AGLHL2016-09-24
04049016053309IFA: Legionella pneumophila Screening (Mix 1 / MixEUROIMMUN Medizinische Labordiagnostika AGLHL2016-09-24
04049016053316IFA: Legionella pneumophila Screening (Mix 1 / MixEUROIMMUN Medizinische Labordiagnostika AGLHL2016-09-24
04049016053323IFA: Legionella pneumophila Screening (Mix 1 / MixEUROIMMUN Medizinische Labordiagnostika AGLHL2016-09-24
04049016053330IFA: Legionella pneumophila Screening (Mix 1 / MixEUROIMMUN Medizinische Labordiagnostika AGLHL2016-09-24
04049016077848IFA: Legionella pneumophila Screening (Mix 1 / MixEUROIMMUN Medizinische Labordiagnostika AGLHL2016-09-24
10816101020017Legionella IFA Polyvalent ConjugateDIASORIN MOLECULAR LLCLHL2016-09-22