FDA.reportPublic FDA data

O. Tsutsugamushi(Scrub Typhus) 12 well; 10 pk

Primary DI
00813545026066
Brand
O. Tsutsugamushi(Scrub Typhus) 12 well; 10 pk
Company
SCIMEDX CORPORATION
Model
I-OTS01X
Catalog number
I-OTS01X
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00813545026066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813545026066008135450260668135450260660813545026066

GMDN Terms#

Term, Definition table
TermDefinition
Orientia tsutsugamushi immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassayA 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 Orientia tsutsugamushi in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Orientia tsutsugamushi, the rickettsial bacteria associated with scrub typhus.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18002215598service@scimedx.com

Regulatory Flags#

DUNS number
155424708
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813545026905MeDiCa1001-481001-482020-11-04
00813545026912MeDiCa1001-961001-962020-11-04
00813545026561MeDiCa010101012020-12-01
00813545026578MeDiCa010201022020-12-01
00813545026776MeDiCa082108212020-12-01
00813545026783MeDiCa082208222020-12-01
00813545026790MeDiCa0821-M0821-M2020-12-01
00813545026806MeDiCa0822-M0822-M2020-12-01
00813545026813MeDiCa083108312020-12-01
00813545026820MeDiCa083208322020-12-01
00813545026837MeDiCa0831-M0831-M2020-12-01
00813545026844MeDiCa0832-M0832-M2020-12-01
00813545026851MeDiCa083308332020-12-01
00813545026868MeDiCa0833-M0833-M2020-12-01
00813545026875MeDiCa083408342020-12-01
00813545026882MeDiCa0834-M0834-M2020-12-01
00813545026899MeDiCa0842-RM0842-M2020-12-01
00813545027223MeDiCa8021-488021-482020-12-01
00813545027261MeDiCa8021-4008021-4002020-12-01
00813545027278MeDiCa8021-96-GI8021-96-GI2020-12-01

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
00840239052971Rickettsia IgG ELISADRG International IncLSQ2021-06-07
B266RTG96K0Rickettsia typhi IgG ELISA KitFULLER LABORATORIESLSQ2019-10-31
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