FDA.reportPublic FDA data

Rickettsia IgG ELISA

Primary DI
00840239052971
Brand
Rickettsia IgG ELISA
Company
DRG International Inc
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
2021-06-07
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
00840239052971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239052971008402390529718402390529710840239052971

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

Regulatory Flags#

DUNS number
075150847
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
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
00613745000015IMMUNODOT™ RICKETTSIA CONORIIGenBioLSQ2025-08-31
00613745000022IMMUNODOT™ Rickettsia TyphiGenBioLSQ2025-08-31
04048474052978Rickettsia IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLSQ2023-09-01
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