FDA.reportPublic FDA data

Rickettsia IgG ELISA

Primary DI
04048474052978
Brand
Rickettsia IgG ELISA
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
EIA-5297
Catalog number
EIA-5297
Device description
The Spotted Fever Group Rickettsia IgG ELISA is intended for the detection of human IgG class antibody to Spotted Fever Group Rickettsia, to be used as an aid in the diagnosis of human infection by these pathogens.
Published
2023-09-01
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
LSQReagent, Rickettsia Serological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSQReagent, Rickettsia SerologicalMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048474052978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048474052978040484740529784048474052978

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Rickettsia species (spotted fever group) 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 the rickettsial bacteria associated with spotted fever in a clinical specimen, using an enzyme immunoassay (EIA) method. Rickettsia species intended to be detected may include Rickettsia rickettsii, R. akari, R. conorii, R. sibirica, R. australis, R. japonica, R. africae, R. honei and/or R. felis.

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
00613745000015IMMUNODOT™ RICKETTSIA CONORIIGenBioLSQ2025-08-31
00613745000022IMMUNODOT™ Rickettsia TyphiGenBioLSQ2025-08-31
00840239052971Rickettsia IgG ELISADRG International IncLSQ2021-06-07
B266RTG96K0Rickettsia typhi IgG ELISA KitFULLER LABORATORIESLSQ2019-10-31
00813545026066O. Tsutsugamushi(Scrub Typhus) 12 well; 10 pkSCIMEDX CORPORATIONLSQ2016-09-21
00813545026073C. burnetii 12 Well 10 pk SCIMEDX CORPORATIONLSQ2016-09-21
00813545026080R. Conorii 12 well; 10 pkSCIMEDX CORPORATIONLSQ2016-09-21
00813545026103R. Prowazekii 12 well; 10 pk SCIMEDX CORPORATIONLSQ2016-09-21
00813545026110R. Rickettsii 12 well; 10 pk SCIMEDX CORPORATIONLSQ2016-09-21
00813545026141Rickettsia typhi 12 well;10 pk SCIMEDX CORPORATIONLSQ2016-09-21
00813545026295Rickettsia rickettsii (RMSF) Latex 30 Test KiSCIMEDX CORPORATIONLSQ2016-09-21
00813545025649Ehrlichia chaffeensis 12wl; 10 pkSCIMEDX CORPORATIONLSQ2016-09-20
10888234001003REStIMMUCOR, INC.LSQ2016-04-19