FDA.reportPublic FDA data

ELISA L. pneumophila IgG/IgM/IgA Smart Kit Test System

Primary DI
00845533000796
Brand
ELISA L. pneumophila IgG/IgM/IgA Smart Kit Test System
Company
ZEUS SCIENTIFIC, INC.
Model
SM3Z15051
Catalog number
SM3Z15051
Device description
The ZEUS ELISA Legionella pneumophila IgG/IgM/IgA Test System is an enzyme-linked immunosorbent assay for the qualitative detection of total antibody (IgG/IgM/IgA) to Legionella pneumophila serogroups 1-6 in human sera. This device is for In Vitro diagnostic use.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845533000796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845533000796008455330007968455330007960845533000796

GMDN Terms#

Term, Definition table
TermDefinition
Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)A 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/or immunoglobulin M (IgM) antibodies to one or multiple serogroups of Legionella pneumophila in a clinical specimen, using an enzyme immunoassay (EIA) 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
080953946
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845533003551Legionella pneumophila (Group 1-6)FA15001FA150012026-05-26
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00845533003575Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgMFA9151MFA9151M2026-05-26
00845533003483Striated Muscle (Rat)5848RL5848RL2026-05-15
00845533003490Alegria Flash PR3CL28141CL281412026-05-15
00845533003506Alegria Flash PR3 Control KitCL28141CKCL28141CK2026-05-15
00845533003513Alegria Flash MPO CL28131CL281312026-05-15
00845533003520Alegria Flash MPO Control KitCL28131CKCL28131CK2026-05-15
00845533003537Alegria Flash GBM CL28151CL281512026-05-15
00845533003544Alegria Flash GBM Control KitCL28151CKCL28151CK2026-05-15
00845533003476Fluorescent Treponemal Antibody-Absorption Titratable (FTA-ABS TT)FA7001TFA7001T2026-04-15
00845533002851Anti-SARS-CoV-2 IgGSM9Z7901GSM9Z7901G2026-04-01
00845533002868Anti-SARS-CoV-2 TotalSM9Z7901SM9Z79012026-04-01
00845533003100Anti-dsDNA2Z2881G2Z2881G2026-04-01
00845533003117Anti-dsDNASM2Z2881GSM2Z2881G2026-04-01
00845533003124Anti-EBV EA IgG9Z9481G9Z9481G2026-04-01
00845533003131Anti-EBV EA IgGSM9Z9481GSM9Z9481G2026-04-01
00845533003148ENA Screen2Z2851G2Z2851G2026-04-01
00845533003155ENA ScreenSM2Z2851GSM2Z2851G2026-04-01
00845533003162Anti-Gliadin IgA2Z61001A2Z61001A2026-04-01