FDA.reportPublic FDA data

Schistosoma Antibody 96 Tests

Primary DI
00813545026455
Brand
Schistosoma Antibody 96 Tests
Company
SCIMEDX CORPORATION
Model
SCHISTO-96
Catalog number
SCHISTO-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
GNHAntigen, Fluorescent Antibody Test, Schistosoma Mansoni

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GNHAntigen, Fluorescent Antibody Test, Schistosoma MansoniMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813545026455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813545026455008135450264558135450264550813545026455

GMDN Terms#

Term, Definition table
TermDefinition
Schistosoma 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 species of the parasitic flatworm Schistosoma in a clinical specimen, using an enzyme immunoassay (EIA) method.

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
ENTISCHG04100NovaLisa Schistosoma mansoni IgGGold Standard Diagnostics Frankfurt GmbHGNH2024-08-26
ENTISCHG0410NovaLisa Schistosoma mansoni IgGGold Standard Diagnostics Frankfurt GmbHGNH2024-08-26
00894175000114AccuDiag ™Diagnostic Automation, Inc.GNH2024-03-06
04048474038729Schistosoma mansoni IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGNH2023-08-31
04048474035124Schistosoma IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGNH2023-08-29
00840239038722Schistosoma mansoni IgG ELISADRG International IncGNH2023-08-25
04049016135449Anti-Schistosoma ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGNH2022-12-08
07640158219607Schistosoma mansoni IgG ELISABordier affinity products S.A.GNH2022-08-09
00840239035127Schistosoma IgG ELISADRG International IncGNH2021-06-07
04049016101727Anti-Schistosoma mansoni IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGNH2016-09-24