FDA.reportPublic FDA data

IFA Mosaic: Legionella non-pneumophila (IgAGM)

Primary DI
04049016085164
Brand
IFA Mosaic: Legionella non-pneumophila (IgAGM)
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
FI 216f-1005-1 P
Published
2016-10-10
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
04049016085164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049016085164040490160851644049016085164

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Legionella species immunoglobulin A (IgA)/IgG/IgM 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 A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to multiple species of Legionella 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#

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
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
04049016045335ANA IFA: HEp-20-10FA 1522-10032016-09-24
04049016045342ANA IFA: HEp-20-10FA 1522-10052016-09-24
04049016045359ANA IFA: HEp-20-10FA 1522-10102016-09-24
04049016045366ANA IFA: HEp-20-10FA 1522-10502016-09-24
04049016045380ANA IFA: HEp-20-10FA 1522-20032016-09-24
04049016045397ANA IFA: HEp-20-10FA 1522-20052016-09-24
04049016045403ANA IFA: HEp-20-10FA 1522-20102016-09-24
04049016099017IFA 40: HEp-20-10FA 1522-1010-12016-09-24
04049016099024IFA 40: HEp-20-10FA 1522-2005-12016-09-24
04049016099031IFA 40: HEp-20-10FA 1522-2010-12016-09-24

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