FDA.reportPublic FDA data

Legionella pneumophila IgG ELISA

Primary DI
04048474056457
Brand
Legionella pneumophila IgG ELISA
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
EIA-5645
Catalog number
EIA-5645
Device description
The Legionella pneumophila IgG ELISA is intended for the qualitative determination of IgG class antibodies against Legionella pneumophila in human serum or plasma (citrate, heparin).
Published
2019-06-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MJHLEGIONELLA, SPP., ELISA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJHLegionella, Spp., ElisaMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048474056457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048474056457040484740564574048474056457

GMDN Terms#

Term, Definition table
TermDefinition
Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin A (IgA), immunoglobulin G (IgG) and/or immunoglobulin M (IgM) antibodies to one or multiple serogroups of Legionella pneumophila bacteria in a clinical specimen.

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
+1(973)564-7555corp@drg-international.com

Regulatory Flags#

DUNS number
317134468
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
04048474041170ANA Detect ELISAEIA-4117EIA-41172023-08-31
04048474027730ANA Screen IgG ELISA EIA-2773EIA-27732023-08-29
04048474035629ANA-8-Screen ELISAEIA-3562EIA-35622019-06-05
04048474035636ANA Combi (ANA-8-Profile) ELISAEIA-3563EIA-35632019-06-10
04048474018646TGF-Beta 1 ELISAEIA-1864EIA-18642024-11-22
04048474059670Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-09-01
04048474060591Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-09-01
04048474027747DNA (ds) IgG ELISAEIA-2774EIA-27742023-08-29
04048474027938Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-29
04048474027945Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-29
04048474027969EBV-EA IgG ELISAEIA-2796EIA-27962023-08-29
04048474028157H. Pylori IgG ELISA EIA-2815EIA-28152023-08-29
04048474033717Gliadin IgG ELISA EIA-3371EIA-33712023-08-29
04048474034448Adenovirus Antigen (stool) ELISA EIA-3444EIA-34442023-08-29
04048474034677Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-29
04048474034738Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-29
04048474034776Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-29
04048474036022Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-29
04048474035520hGH ELISAEIA-3552EIA-35522019-06-10
04048474035612Anti TPO Ab ELISAEIA-3561EIA-35612019-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840239056450Legionella pneumophila IgG ELISADRG International IncMJH2023-08-25
05032384013227LEGIONELLA SPECIES TEST KITOXOID LIMITEDMJH2022-12-08
05713106105573ImmuView S. pneumoniae and L. pneumophila urinary antigen testSsi Diagnostica A/SMJH2022-10-25
05713106024515ImmuView S. pneumoniae and L. pneumophila urinary antigen testSsi Diagnostica A/SMJH2020-03-24
05391516746670BartelsCLARK LABORATORIES, INC.MJH2019-11-06
10811877011054BinaxNOW™ Legionella Control Swab PackAlere Scarborough, Inc.MJH2019-07-15
10811877011023BinaxNOW Legionella Urinary Antigen CardAlere Scarborough, Inc.MJH2019-07-08
00404847456455Legionella pneumophila IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungMJH2019-06-10
04049016027508Anti-Legionella pneumophila ELISA (IgA)EUROIMMUN Medizinische Labordiagnostika AGMJH2016-09-24
04049016027515Anti-Legionella pneumophila ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGMJH2016-09-24
04049016027522Anti-Legionella pneumophila ELISA (IgM)EUROIMMUN Medizinische Labordiagnostika AGMJH2016-09-24
05032384013197NAOXOID LIMITEDMJH2016-09-24
05032384013203NAOXOID LIMITEDMJH2016-09-24
05032384013210NAOXOID LIMITEDMJH2016-09-24
05032384060535NAOXOID LIMITEDMJH2016-09-24
05032384060542NAOXOID LIMITEDMJH2016-09-24
05032384061365NAOXOID LIMITEDMJH2016-09-24
00840733101267TRU LegionellaMERIDIAN BIOSCIENCE, INC.MJH2016-09-23
05391516744065Trinity BiotechCLARK LABORATORIES, INC.MJH2016-09-23
05391516747202Trinity BiotechCLARK LABORATORIES, INC.MJH2016-09-19
10811877010460Binax® Legionella Urinary Antigen EIAAlere Scarborough, Inc.MJH2016-09-03
10811877010767Binax® Legionella EIA Wash Buffer Accessory KitAlere Scarborough, Inc.MJH2016-09-03
10811877010491Alere™ BinaxNOW® Legionella Control Swab KitAlere Scarborough, Inc.MJH2016-09-01
10811877010477Alere™ BinaxNOW® Legionella Urinary Antigen CardAlere Scarborough, Inc.MJH2016-09-01