FDA.reportPublic FDA data

AccuDiag ™

Primary DI
00850049545907
Brand
AccuDiag ™
Company
Diagnostic Automation, Inc.
Model
DACD351-50
Catalog number
351-50
Device description
AccuDiag ™ SLE Latex Test Kit is a latex slide agglutination assay for the qualitative and semiquantitative detection of anti-deoxyribonucleoprotein (anti-DNP) in human serum
Published
2023-06-14
Public version status
New
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
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
00850049545907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850049545907008500495459078500495459070850049545907

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
818-591-3030Onestep@rapidtest.com

Regulatory Flags#

DUNS number
878252071
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850054026446AccuDiag™ T3 ELISA KitDACD3144-153144-152026-03-02
00850082766024AccuDiag™ Mycoplasma pneumoniae IgG ELISADACD8042-28042-22026-03-02
00894175000725AccuDiag™ ENA Profile-6 (Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B) ELISA DACD2506-22506-22026-02-27
00850049545433AccuDiag™ Prolactin (PRL) ELISADACD4226-154226-152026-01-30
00850054026712AccuDiag™ LH ELISADACD4225-154225-152026-01-30
00894175000800AccuDiag™ Progesterone ELISADACD2077-152077-152026-01-30
00850054026569QMedix™DACD5102-25102-22024-04-23
00850049545723AccuDiag™ Insulin ELISADACD1606-151606-152026-01-27
00850049545815AccuDiag™ Human Growth Hormone (HGH) ELISADACD1901-151901-152026-01-27
00850054026255AccuDiag™ C-Peptide ELISA KitDACD1293-151293-152026-01-27
00850054026682AccuDiag™ Estradiol ELISA DACD2046-152046-152026-01-27
00850054026705 AccuDiag™ FSH ELISADACD4224-154224-152026-01-27
00850082766017AccuDiag™ Free Estriol ELISA DACD3171-153171-152026-01-27
00894175000770AccuDiag™ 17-alpha-OH Progesterone ELISADACD1292-151292-152026-01-27
00894175000824AccuDiag™ ANST (Androstenedione) ELISADACD1038-151038-152026-01-27
10850049545492QMedix™DACD104110-1-19104110-1-192025-12-24
10850082766007QMedix™DACD113030-1-19113030-1-192025-12-24
00850049545501Diagnostic Automation, Inc.DAI SF2100SF21002025-12-24
00850054026392Diagnostic Automation, Inc.DAI SF2600SF26002025-12-24
00850049545495QMedix™DACD104110-1-19104110-1-192025-12-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10722355001729Detector 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