DIAGNOSYS LLC

FETOLY-HEART

2024-09-11

Diagnoly

STA R Max 3, STA Compact Max 3

2023-06-07

Diagnostica Stago S.A.S

STA- NeoPTimal

2022-12-23

Diagnostica Stago S.A.S

System, Test, Automated Blood Grouping And Antibody

2022-12-07

Diagnostic Grifols, S. A.

E3 and Profile

2022-11-22

Diagnosys, LLC

Blood Establishment Computer Software And Accessories

2022-09-09

Diagnostic Grifols, S. A.

Quality Control Kits For Blood Banking Reagents

2020-05-07

DIAGAST

Automated Blood Grouping And Antibody Test Systems

2020-04-23

Diagnostic Grifols, S. A.

Automated Blood Grouping And Antibody Test Systems

2019-12-10

Diagnostic Grifols, S. A.

Automated Blood Grouping And Antibody Test Systems

2019-12-10

Diagnostic Grifols, S. A.

Automated Blood Grouping And Antibody Test Systems

2019-12-10

Diagnostic Grifols, S. A.

Automated Blood Grouping And Antibody Test Systems

2019-10-11

Diagnostic Grifols, S. A.

QNext And DG-PT

2019-08-21

Diagnostic Grifols, S.A.

Automated Blood Grouping And Antibody Test Systems

2018-12-20

Diagnostic Grifols, S. A.

Automated Blood Grouping And Antibody Test Systems

2018-12-20

Diagnostic Grifols, S. A.

Panther Fusion GBS Assay

2018-07-27

Diagenode

Quality Control Kits For Blood Banking Reagents

2018-02-02

DIAGAST

Automated Blood Grouping And Antibody Test Systems

2017-11-01

Diagnostic Grifols, S. A.

STA® - Liatest® D-Di

2016-12-10

Diagnostica Stago

Automated Blood Grouping And Antibody Test Systems

2016-11-09

Diagnostic Grifols, S. A.

STA R MAX

2015-08-07

DIAGNOSTICA STAGO S.A.S.

Automated Blood Grouping And Antibody Test Systems

2015-07-28

Diagnostic Grifols, S. A.

GSI TympStar Pro Middle Ear Analyzer

2015-06-25

Diagnostic Group, Dba Grason-Stadler

POOL NORM

2014-12-12

Diagnostics Stago S.A.S.

STA LIATEST D-DI

2014-09-03

DIAGNOSTICA STAGO

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2014-05-21

Diagnostic Grifols, S. A.

DMS 300-2W HOLTER ECG RECORDER

2014-05-19

DIAGNOSTIC MONITORING SOFTWARE

FORESEE (4C) IMAGING SYSTEM

2014-03-17

DIAGNOSTIC PHOTONICS, INC

Automated Blood Grouping And Antibody Test Systems

2014-01-17

Diagnostic Grifols, S. A.

Automated Blood Grouping And Antibody Test Systems

2013-08-30

Diagnostic Grifols, S. A.

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2013-07-19

Diagnostic Grifols, S. A.

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2013-07-19

Diagnostic Grifols, S. A.

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2013-07-19

Diagnostic Grifols, S. A.

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2013-07-19

Diagnostic Grifols, S. A.

STA- COAG CONTROL (N+ABN) PLUS

2013-03-14

DIAGNOSTICA STAGO, INC.

STA COMPACT MAX

2013-02-12

DIAGNOSTICA STAGO, INCORPORATED

STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH

2011-10-26

DIAGNOSTICA STAGO, INC.

VIRTUE

2011-09-21

DIAGNOSOFT, INC.

SYPHILIS HEALTH CHECK

2011-08-01

DIAGNOSTICS DIRECT, LLC.

CARA

2011-07-14

DIAGNOS, INC

040811

DIAGNOSTIC GREEN

CARA - CARA is an innovative software program that uses enhanced digital images to support and identify the early detection of vision loss and more specifically diabetic retinopathy. CARA is a teleophthalmology platform which includes advanced retinal imaging technology and clinical grading services by eye care professionals.

Diagnos Inc

2018-06-04

FETOLY - 3

DIAGNOLY

2026-03-18

FETOLY - FETOLY is a software that aims at helping sonographers, obstetricians, radiologists, maternal-fetal medicine specialists and pediatric cardiologists (designated as Healthcare Professionals i.e. HCPs) to perform fetal ultrasound examinations of fetal brain and heart in real-time. FETOLY can be used by HCPs during fetal ultrasound examination in the second and third trimesters (gestational age window: from 17 to 40 weeks).The software is intended to assist HCPs in the completeness assessment of fetal brain and heart ultrasound examination in accordance with national and international guidelines. FETOLY is also intended to be used to realize biometric measurements of the fetal brain and heart in accordance with national and international guidelines.

DIAGNOLY

2025-09-15

FETOLY - FETOLY is a software that aims at helping sonographers, obstetricians, radiologists, maternal-fetal medicine specialists and pediatric cardiologists (designated as Healthcare Professionals i.e. HCPs) to perform fetal ultrasound examinations of fetal brain and heart in real-time. FETOLY can be used by HCPs during fetal ultrasound examination in the second and third trimesters (gestational age window: from 17 to 40 weeks).The software is intended to assist HCPs in the completeness assessment of fetal brain and heart ultrasound examination in accordance with national and international guidelines. FETOLY is also intended to be used to realize biometric measurements of the fetal brain and heart in accordance with national and international guidelines.

DIAGNOLY

2025-09-29

AccuDiag™ Mycoplasma pneumoniae IgG ELISA - AccuDiag™ Mycoplasma pneumoniae IgG ELISAThe ELISA Mycoplasma pneumoniae IgG Test System provides a means for the qualitative detection of IgG antibodies to Mycoplasma pneumoniae in human sera. The test may aid in the determination of the patient’s serological status or may aid in the diagnosis of disease associated with Mycoplasma pneumoniae.

Diagnostic Automation, Inc.

2026-03-02

AccuDiag™ T3 ELISA Kit - AccuDiag™ T3 ELISA KitA collection of reagents and other associated materials intended to be used for the quantitative measurement of total triiodothyronine (TT3) in a clinical specimen, using an enzyme immunoassay.

Diagnostic Automation, Inc.

2026-03-02

AccuDiag™ ENA Profile-6 (Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B) ELISA - AccuDiag™ ENA Profile-6 (Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B) ELISA KitA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple extractable nuclear antigens (ENA) in a clinical specimen

Diagnostic Automation, Inc.

2026-02-27

QMedix™ - QMedix™ ANA Screen ELISA

Diagnostic Automation, Inc.

2024-04-23

AccuDiag™ Progesterone ELISA - AccuDiag™ Progesterone ELISAA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of progesterone in a clinical specimen, using an enzyme immunoassay (EIA) method.

Diagnostic Automation, Inc.

2026-01-30

AccuDiag™ LH ELISA - AccuDiag™ (Luteinizing hormone ) LH ELISA

Diagnostic Automation, Inc.

2026-01-30

AccuDiag™ Prolactin (PRL) ELISA - AccuDiag™ Prolactin (PRL) ELISAA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of prolactin in a clinical specimen, using an enzyme immunoassay (EIA) method.

Diagnostic Automation, Inc.

2026-01-30

AccuDiag™ ANST (Androstenedione) ELISA - DACD1038-15

Diagnostic Automation, Inc.

2026-01-27

AccuDiag™ 17-alpha-OH Progesterone ELISA - AccuDiag™ 17-alpha-OH Progesterone ELISAA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of 17-hydroxyprogesterone in a clinical specimen, using an enzyme immunoassay (EIA) method

Diagnostic Automation, Inc.

2026-01-27

AccuDiag™ Free Estriol ELISA - AccuDiag™ Free Estriol ELISA A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free estriol (oestriol) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Diagnostic Automation, Inc.

2026-01-27

AccuDiag™ FSH ELISA - DACD4224-15

Diagnostic Automation, Inc.

2026-01-27

AccuDiag™ Estradiol ELISA - AccuDiag™ Estradiol ELISA KitA collection of reagents and other associated materials intended to be used for the quantitative measurement of the estrogen hormone estradiol in a clinical specimen, using an enzyme immunoassay (EIA) method.

Diagnostic Automation, Inc.

2026-01-27

AccuDiag™ C-Peptide ELISA Kit - AccuDiag™ C-Peptide ELISA KitA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of C-peptide in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used in the evaluation of insulin levels as an aid in the diagnosis of hypoglycaemia and insulinoma.

Diagnostic Automation, Inc.

2026-01-27

AccuDiag™ Human Growth Hormone (HGH) ELISA - AccuDiag™ Human Growth Hormone (HGH) ELISAA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of human growth hormone (HGH) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Diagnostic Automation, Inc.

2026-01-27

AccuDiag™ Insulin ELISA - AccuDiag™ Insulin ELISAA collection of reagents and other associated materials intended to be used for the quantitative measurement of insulin in a clinical specimen, using an enzyme immunoassay (EIA) method.

Diagnostic Automation, Inc.

2026-01-27

QMedix™ - QMedix™ hCG Combo Urine/Serum/Plasma RapiDip™ InstaTest

Diagnostic Automation, Inc.

2025-12-24

QMedix™ - QMedix™ LH Ovulation Urine RapiCard™ InstaTest

Diagnostic Automation, Inc.

2025-12-24

FETOLY-HEART - Fetoly-Heart is a software that aims at helping sonographers, obstetricians, radiologists, maternal-fetal medicine specialists, and pediatric cardiologists (designated as healthcare professionals i.e. HCPs) to perform fetal ultrasound examinations of the fetal heart in real-time. Fetoly-Heart can be used by HCPs during fetal ultrasound examinations in the second and third trimesters (gestational age window: from 17 to 40 weeks). The software is intended to assist HCPs in the completeness assessment of the fetal heart ultrasound examination in accordance with national and international guidelines.

DIAGNOLY

2024-10-25

Beckman Coulter® PK® Systems Anti-e (P3GD512+MS63) - Blood Grouping Reagent Anti-e (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® 7300 Systems

DIAGAST

2015-09-04

Beckman Coulter® PK® Systems Control - Blood Grouping Reagent Control, formulated for Automated Systems, Beckman Coulter® PK® System

DIAGAST

2016-01-12

Beckman Coulter® PK® Systems Bromelin - Red Blood Cells Diluent, formulated for Automated Systems, Beckman Coulter® PK® System

DIAGAST

2015-09-18

Alpha2-macroglobulin - In vitro diagnostic reagent for the quantitative determination of alpha2macroglobulin in samples of human origin (serum, heparinized plasma) by immunoturbidimetry on the cobas c systems.

Diagam

2021-12-07

Anti-Human Globulin Anti-IgG,-C3d, polyspecific - Clear - Anti-Human Globulin Anti-IgG,-C3d (Murine Monoclonal) (18833+18896+12011D10) is intended for use in the direct antiglobulin test to detect the in vivo coating on human red blood cells with IgG and/or C3d components. In addition to recognizing IgG antibodies and the complement fragment C3d, Anti Human Globulin Anti-IgG, C3d is able to recognize IgM antibodies on the surface of red blood cells since IgM antibodies always fix complement

DIAGAST

2018-05-01

Anti-Human Globulin Anti-IgG - Clear - Anti-Human Globulin Anti-IgG (Murine Monoclonal) (18833+18896) is intended for use in the direct antiglobulin test to detect in vivo coating on human red blood cells with IgG and for the indirect antiglobulin test for antibody screening and identification, and crossmatch and for erythrocyte phenotyping with blood phenotyping reagents requiring an indirect antiglobulin test method.

DIAGAST

2018-05-01

Anti-Human Globulin Anti-IgG - Green - Anti-Human Globulin Anti-IgG (Murine Monoclonal) (18833+18896) is intended for use in the direct antiglobulin test to detect in vivo coating on human red blood cells with IgG and for the indirect antiglobulin test for antibody screening and identification, and crossmatch and for erythrocyte phenotyping with blood phenotyping reagents requiring an indirect antiglobulin test method.

DIAGAST

2018-05-01

Anti-Human Globulin Anti-IgG,-C3d, polyspecific - Green - Anti-Human Globulin Anti-IgG,-C3d (Murine Monoclonal) (18833+18896+12011D10) is intended for use in the direct antiglobulin test to detect the in vivo coating on human red blood cells with IgG and/or C3d components. In addition to recognizing IgG antibodies and the complement fragment C3d, Anti Human Globulin Anti-IgG, C3d is able to recognize IgM antibodies on the surface of red blood cells since IgM antibodies always fix complement

DIAGAST

2018-05-01

Mycoplama genitalium IVT Wild type control - In vitro transcript of Mycoplasma genitalium 23S RNA

Diagenode

2021-03-15

Mycoplasma genitamium macrolide resistance IVT A 2059G control - In vitro transcript of mycoplasma genitalium 23S RNA including A2059G mutation

Diagenode

2021-03-15

Mycoplasma genitalium macrolide resistance IVT A2059C Control - In vitro transcript of Mycoplama genitalium 23S RNA including A 2059C mutation

Diagenode

2021-03-15

Mycoplasma genitalium macrolide resistance IVT A2058T Controls - In vitro transcript of Mycoplasma genitalium 23S RNA including A2058T mutation

Diagenode

2021-03-15

Mycoplasma genitalium macrolide resistance IVT A2058G Control - In vitro transcript of Mycoplasma genitalium 23S RNA including A2058G mutation

Diagenode

2021-03-15

Mycoplasma genitalium Macrolide Resistance IVT A2058C Control - In vitro transcript of Mycoplasma genitalium 23S RNA including A2058C mutation

Diagenode

2021-03-15

Mycoplasma genitalium macrolide resistance probes - Oligunucleotides designed to detect mutations associated to macrolide resistance on 23S RNA (A2058C, 2058G, 2058T, 2059C, A2059G). These oligonucleotides contain a 5' FAM label and a 3' BHQ-1 label

Diagenode

2021-03-15

Mycoplasma genitalium macrolide resistance primers - Oligonucleotides designed to detect the mutations associated to macrolide resistance on 23S RNA (A2058C, A2058G, A2058T, A2058C and A2059G)

Diagenode

2021-03-15

Beckman Coulter® PK® Systems Anti-e (P3GD512+MS16+MS21+MS63) - Blood Grouping Reagent Anti-e (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK®7400 Systems

DIAGAST

2020-10-20

Beckman Coulter® PK® Systems Reagent Red Blood Cells (A1 & B) - Reagent Red Blood Cells A1 and B cells formulated for the use in Beckman Coulter® PK® Systems

DIAGAST

2015-09-04