FDA.reportPublic FDA data

Leptospira IgG ELISA

Primary DI
04048474042450
Brand
Leptospira IgG ELISA
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
EIA-4245
Catalog number
EIA-4245
Device description
The Leptospira IgG ELISA test is an enzyme immunoassay for the detection of antibodies to Leptospira biflexa (serovar patoc 1) for the serological confirmation of infections in serum and plasma.
Published
2023-08-31
Public version status
New
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
GRYAntigens, All, Leptospira Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GRYAntigens, All, Leptospira Spp.Microbiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048474042450PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048474042450040484740424504048474042450

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Leptospira species immunoglobulin G (IgG) 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 G (IgG) antibodies to one or multiple species of Leptospira bacteria in a clinical specimen, using an enzyme immunoassay (EIA) method.

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
973-564-7555corp@drg-international.com

Regulatory Flags#

DUNS number
317134468
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
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
ENTILEPG06600NovaLisa Leptospira IgGGold Standard Diagnostics Frankfurt GmbHGRY2024-08-26
ENTILEPG0660NovaLisa Leptospira IgGGold Standard Diagnostics Frankfurt GmbHGRY2024-08-26
00850049545211AccuDiag ™Diagnostic Automation, Inc.GRY2024-03-06
00840239057518Leptospira IgG ELISA DRG International IncGRY2023-08-25
04048474057515Leptopspira IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGRY2019-06-10
00404847457513Leptopspira IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGRY2019-06-10
00840239042453Leptopspira IgG ELISADRG International IncGRY2019-06-05
00613745000046ImmunoDOT Leptospira IgMGenBioGRY2016-09-24
00613745000152ImmunoDOT Leptospira IgMGenBioGRY2016-09-24
00613745000169ImmunoDOT Leptospira IgMGenBioGRY2016-09-24
00813545026318Leptospira IgG Antibody 96 Test SCIMEDX CORPORATIONGRY2016-09-21