FDA.reportPublic FDA data

Detector Lex SLE

Primary DI
10722355001729
Brand
Detector Lex SLE
Company
Immunostics Company, Inc
Model
SLE-100
Device description
A rapid undiluted latex agglutination slide test for the detection of anti-nucleoprotein serum factors associated with systemic lupus erythematosus (sLE)
Published
2016-09-21
Public version status
Update
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
DHCSYSTEM, TEST, SYSTEMIC LUPUS ERYTHEMATOSUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHCSystem, Test, Systemic Lupus ErythematosusImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10722355001729PrimaryGS10
80722355001728Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1072235500172910722355001729
8072235500172880722355001728

GMDN Terms#

Term, Definition table
TermDefinition
Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple antibodies associated with systemic lupus erythematosus (SLE) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(732)918-0770technical@immunostics.com

Regulatory Flags#

DUNS number
119214195
Device count
100
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10722355002894hema-screen SPECIFIC GOLDHSGD-25HSGD-252025-04-16
10722355002900hema-screen SPECIFIC GOLDHSGDCAS-25HSGDCAS-252025-04-16
10722355003068hema-screen SPECIFIC GOLDHSGDENV-20HSGDENV-202025-04-16
10722355001002hema-screenHS-502016-09-23
10722355001019hema-screenHS-1002016-09-23
10722355001026hema-screenHS-10002016-09-23
10722355001033hema-screenHS-342016-09-23
10722355001040hema-screenHSPP-502016-09-23
10722355001057hema-screen STATHSTAT-502016-09-23
10722355001071hema-screen SPECIFICHSSP-252016-09-21
10722355001095hema-screen SPECIFICHSSPCAS-252016-09-21
10722355001101hema-screen SPECIFICHSSPENV-202016-09-21
10722355001125hema-screenHSDV-82016-09-23
10722355001255Detector MonoIDM-252016-09-22
10722355001453Detector PersonalIDP-32016-09-20
10722355001668Detector Strep AIST-501-OBC33IDSTREP-252016-09-21
10722355002016Detector H. pyloriIHP-102016-09-22
10722355002023Detector H. pyloriIHP-302016-09-22
10722355002146hema-screen Triple 335HSTR-335CS2016-09-23
10722355002221Detector UA 10IDU-102016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850049545907AccuDiag ™Diagnostic Automation, Inc.DHC2023-06-14
00813545026585MeDiCaSCIMEDX CORPORATIONDHC2020-12-01
00813545026592MeDiCaSCIMEDX CORPORATIONDHC2020-12-01
00813545026929MeDiCaSCIMEDX CORPORATIONDHC2020-11-04
00813545026936MeDiCaSCIMEDX CORPORATIONDHC2020-11-04
00813545026943MeDiCaSCIMEDX CORPORATIONDHC2020-11-04
10722355001712Detector Lex SLEImmunostics Company, IncDHC2016-09-21
00847817018206Autoimmune EIABIO-RAD LABORATORIES, INC.DHC2016-09-12
00847817018213Autoimmune EIABIO-RAD LABORATORIES, INC.DHC2016-09-12
00847817018220Autoimmune EIABIO-RAD LABORATORIES, INC.DHC2016-09-12
00847817018237Autoimmune EIABIO-RAD LABORATORIES, INC.DHC2016-09-12
00847817018244Autoimmune EIABIO-RAD LABORATORIES, INC.DHC2016-09-12
00847817018251Autoimmune EIABIO-RAD LABORATORIES, INC.DHC2016-09-12
00847817018268Autoimmune EIABIO-RAD LABORATORIES, INC.DHC2016-09-12
00847817018275Autoimmune EIABIO-RAD LABORATORIES, INC.DHC2016-09-12
00847817018282Autoimmune EIABIO-RAD LABORATORIES, INC.DHC2016-09-12
00855360006120Corgenix Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit (192 Well)CORGENIX MEDICAL CORPORATIONDHC2016-07-14
00855360006137Corgenix Anti-Phosphatidylserine IgM Semi-Quantitative Test Kit (192 Well)CORGENIX MEDICAL CORPORATIONDHC2016-07-14
00855360006212REAADS IgG Anti-Prothrombin Semi-Quantitative Test Kit CORGENIX MEDICAL CORPORATIONDHC2016-07-14
00816057020195ASI SLE Slide TestARLINGTON SCIENTIFIC, INC.DHC2016-07-08
00816057020201ASI SLE Slide TestARLINGTON SCIENTIFIC, INC.DHC2016-07-08
00816057020218ASI SLE Slide TestARLINGTON SCIENTIFIC, INC.DHC2016-07-08
00816057020225ASI SLE Slide TestARLINGTON SCIENTIFIC, INC.DHC2016-07-08
00816057020232ASI SLE Slide TestARLINGTON SCIENTIFIC, INC.DHC2016-07-08
00816057020249ASI SLE Slide TestARLINGTON SCIENTIFIC, INC.DHC2016-07-08
00816057020256ASI SLE Slide TestARLINGTON SCIENTIFIC, INC.DHC2016-07-08
00816057021604ASI SLE Slide Test Control SetARLINGTON SCIENTIFIC, INC.DHC2016-07-08