FDA.reportPublic FDA data

Leptopspira IgG ELISA

Primary DI
00840239042453
Brand
Leptopspira IgG ELISA
Company
DRG International Inc
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
2019-06-05
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
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
00840239042453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239042453008402390424538402390424530840239042453

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

Regulatory Flags#

DUNS number
075150847
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
00840239041173ANA Detect ELISAEIA-4117EIA-41172023-08-25
00840239035622ANA-8-Screen ELISAEIA-3562EIA-35622023-08-24
00840239035639ANA-8-Profile ELISAEIA-3563EIA-35632023-08-24
00840239027733ANA Screen IgG ELISA EIA-2773EIA-27732023-08-23
00840239035899Anti-Cardiolipin Screen ELISAEIA-3589EIA-35892023-08-25
00840239035967c-ANCA (PR3) ELISAEIA-3596EIA-35962023-08-25
00840239036025Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-25
00840239059673Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-08-26
00840239060594Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-08-26
00840239027931Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-24
00840239027948Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-24
00840239027962EBV-EA IgG ELISAEIA-2796EIA-27962023-08-24
00840239028150H. Pylori IgG ELISA EIA-2815EIA-28152023-08-24
00840239033710Gliadin IgG ELISA EIA-3371EIA-33712023-08-24
00840239034670Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-24
00840239034731Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-24
00840239034779Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-24
00840239035523HGH (Human Growth Hormone) ELISAEIA-3552EIA-35522023-08-24
00840239035615Anti TPO Ab ELISAEIA-3561EIA-35612023-08-24
00840239035646Anti-dsDNA IgM ELISAEIA-3564EIA-35642023-08-24

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
04048474042450Leptospira IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungGRY2023-08-31
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
00613745000046ImmunoDOT Leptospira IgMGenBioGRY2016-09-24
00613745000152ImmunoDOT Leptospira IgMGenBioGRY2016-09-24
00613745000169ImmunoDOT Leptospira IgMGenBioGRY2016-09-24
00813545026318Leptospira IgG Antibody 96 Test SCIMEDX CORPORATIONGRY2016-09-21