Diagnostic Automation, Inc.

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Test, Rheumatoid Factor (DHR) (2) Antibodies, Gliadin (MST) (1) Colorimeter, Photometer, Spectrophotometer For Clinical Use (JJQ) (1) Immunoassay Method, Troponin Subunit (MMI) (1) System, Test, C-Reactive Protein (DCN) (1) Test System, Antineutrophil Cytoplasmic Antibodies (Anca) (MOB) (1) Anti-Dna Antibody, Antigen And Control (LSW) (1) Transferrin, Antigen, Antiserum, Control (DDG) (1)

Premarket Exempt

No Yes

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AccuDiag ™ - 00894175000220 Catalog Number : 2556-2

Device Description : AccuDiag ™ SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EI AccuDiag ™ SSB/La antibody (Sjogren's 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 anti-SSB or anti-La antibodies (Sjogren's antibodies) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Device Class :

Duns Number: 878252071

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

AccuDiag ™ - 00894175000237 Catalog Number : 2553-1

Device Description : AccuDiag ™ dsDNA Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme imm AccuDiag ™ dsDNA Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)

Device Class : 2

Duns Number: 878252071

Premarket Exempt : No

Product Code : LSW

Prescription Use : No

Device Count : 1

AccuDiag™ - 00894175000312 Catalog Number : 310-100

Device Description : AccuDiag™CRP Latex Test KitC- Reactive Protein (CRP) latex slide test is used fo AccuDiag™CRP Latex Test KitC- Reactive Protein (CRP) latex slide test is used for the qualitative and semi-quantitative measurement of C-reactive protein (CRP) in human serum.

Device Class : 2

Duns Number: 878252071

Premarket Exempt : No

Product Code : DCN

Prescription Use : No

Device Count : 1

AccuDiag ™ - 00894175000336 Catalog Number : 2550-1

Device Description : AccuDiag ™ Rheumatoid factor IVD, kit, enzyme immunoassay (EIA)The Diagnostic A AccuDiag ™ Rheumatoid factor IVD, kit, enzyme immunoassay (EIA)The Diagnostic Automation Rheumatoid Factor (RF) Enzyme-Linked Immu-nosorbent Assay (ELISA) is intended for the detection of IgM antibodies in human serum to RF antigen and as an aid in the diagnosis of rheumatoid arthritis. For in vitro diagnostic use. High complexity test.

Device Class : 2

Duns Number: 878252071

Premarket Exempt : No

Product Code : DHR

Prescription Use : No

Device Count : 1

AccuDiag™ - 00894175000381 Catalog Number : 320-100

Device Description : AccuDiag™ RF Latex Test KitFor the qualitative and semi-quantitative measurement AccuDiag™ RF Latex Test KitFor the qualitative and semi-quantitative measurement of RF in human serum.

Device Class : 2

Duns Number: 878252071

Premarket Exempt : No

Product Code : DHR

Prescription Use : No

Device Count : 1

AccuDiag ™ - 00894175000404 Catalog Number : 1681-2

Device Description : AccuDiag ™ ANCA Screen IgG ELISA Kit A collection of reagents and other associa AccuDiag ™ ANCA Screen IgG ELISA Kit A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with vasculitis in a clinical specimen, using an enzyme immunoassay (EIA) method. The assayed antibodies may include autoimmune antibodies directed at the glomerular basement membrane (GBM), anti-neutrophil cytoplasmic antibodies to myeloperoxidase (ANCA MPO) and/or anti-neutrophil cytoplasmic antibodies to proteinase-3 (PR3).

Device Class : 2

Duns Number: 878252071

Premarket Exempt : No

Product Code : MOB

Prescription Use : No

Device Count : 1

AccuDiag ™ - 00894175000428 Catalog Number : 1021-2

Device Description : AccuDiag ™ Gliadin IgGMultiple Coeliac disease-associated antibody IVD, kit, enz AccuDiag ™ Gliadin IgGMultiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA)AccuDiag ™ Gliadin IgG ELISA Gliadin IgG Test System is intended for the qualitative and semi-quantitative detection of IgG-class antibodies to gliadin in human serum. The Test System is intended to be used as an aid in the diagnosis of gastrointestinal disorders, mainly Celiac Disease. This test is for In Vitro diagnostic use.

Device Class : 2

Duns Number: 878252071

Premarket Exempt : No

Product Code : MST

Prescription Use : No

Device Count : 1

RapiCard™ InstaTest - 00894175000466 Catalog Number : 166772-1-19

Device Description : OneStep Troponin I RapiCard™ InstaTest (Serum/WB)A collection of reagents and ot OneStep Troponin I RapiCard™ InstaTest (Serum/WB)A collection of reagents and other associated materials intended to be used for the qualitative detection of troponin I in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Device Class :

Duns Number: 878252071

Premarket Exempt : No

Product Code : MMI

Prescription Use : No

Device Count : 25

AccuDiag™ - 00894175000473 Catalog Number : 3126-15

Device Description : AccuDiag™ sTfR - Soluble Transferrin Receptor ELISA KitA collection of reagents AccuDiag™ sTfR - Soluble Transferrin Receptor ELISA KitA collection of reagents and other associated materials intended to be used for the quantitative measurement of soluble transferrin receptor protein in a clinical specimen, using an enzyme immunoassay (EIA) method.

Device Class : 2

Duns Number: 878252071

Premarket Exempt : No

Product Code : DDG

Prescription Use : No

Device Count : 1

Diagnostic Automation - 00894175000480 Catalog Number : DAR800TS

Device Description : DA800TS Microplate Reader is an affordable, high-quality microplate reader for a DA800TS Microplate Reader is an affordable, high-quality microplate reader for assays in 6- to 96-well formats. The color touchscreen provides a visual user interface, making programming simple. The onboard software includes “quick read” and custom protocols, with data viewed immediately after measure, followed by export to USB or to the compact printer.

Device Class : 1

Duns Number: 878252071

Premarket Exempt : Yes

Product Code : JJQ

Prescription Use : No

Device Count : 1

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