FDA.reportPublic FDA data

T.solium Antibody 96 Tests

Primary DI
00813545026509
Brand
T.solium Antibody 96 Tests
Company
SCIMEDX CORPORATION
Model
TS-96
Catalog number
TS-96
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
MDJReagents, Cysticercosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDJReagents, CysticercosisMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813545026509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813545026509008135450265098135450265090813545026509

GMDN Terms#

Term, Definition table
TermDefinition
Taenia solium 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 Taenia solium in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Taenia solium, the parasitic tapeworm associated with cysticercosis.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18002215598service@scimedx.com

Regulatory Flags#

DUNS number
155424708
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
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
ENTITAEG04200NovaLisa Taenia solium IgGGold Standard Diagnostics Frankfurt GmbHMDJ2024-08-27
ENTITOCG04500NovaLisa Toxocara canis IgGGold Standard Diagnostics Frankfurt GmbHMDJ2024-08-27
ENTITAEG0420NovaLisa Taenia solium IgGGold Standard Diagnostics Frankfurt GmbHMDJ2024-08-27
ENTITOCG0450NovaLisa Toxocara canis IgGGold Standard Diagnostics Frankfurt GmbHMDJ2024-08-27
00894175000299AccuDiag ™Diagnostic Automation, Inc.MDJ2024-03-06
04048474035131Taenia Solium IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungMDJ2023-08-29
04049016141112Anti-Toxocara ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGMDJ2022-12-08
B350GSD0130010Toxocara canis IgG ELISA Test KitGold Standard Diagnostics CorporationMDJ2022-10-14
07640158219201Toxocara canis IgG ELISABordier affinity products S.A.MDJ2022-09-28
07640158219706Taenia solium IgG ELISA Bordier affinity products S.A.MDJ2022-09-21
00840239035134Taenia Solium IgG ELISADRG International IncMDJ2021-06-07
B350GSD0130000GSD Toxocara canis IgG ELISAGold Standard Diagnostics CorporationMDJ2017-07-12