Medical Device Catalogue

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SHBG AccuBind ELISA Test System - 192 Wells 9125-300

Monobind, Inc.,United States Class I

Active CE IVDD EUDAMEDGUDID I
IgG Anti-nDNA Fluorescent Test System 3005G

Immuno Concepts Inc,United States(FDA 510(k) applicant) Not classified

Active CE IVDD EUDAMEDGUDID —
HEp-2000® IgG Fluorescent ANA-Ro Test System 8400CS-Ro

Immuno Concepts Inc,United States(FDA 510(k) applicant) Not classified

Active CE IVDD EUDAMEDGUDID —
DHEA AccuLite CLIA Test System - 192 Wells 7475-300

Monobind, Inc.,United States Class I

Active CE IVDD EUDAMEDGUDID I
Fluorescent ANA Test System 8021.1

Immuno Concepts Inc,United States(FDA 510(k) applicant) Not classified

Active CE IVDD EUDAMEDGUDID —
RELISA® Cardiolipin IgG & IgM Antibody Test 8192

Immuno Concepts Inc,United States(FDA 510(k) applicant) Not classified

Active CE IVDD EUDAMEDGUDID —
Histofluor® Rodent LKS Fluorescent Antibody Test System 12160-04

Immuno Concepts Inc,United States(FDA 510(k) applicant) Not classified

Active CE IVDD EUDAMEDGUDID —
CEA AccuBind ELISA Test System - 192 Wells 1825-300

Monobind, Inc.,United States Class II

Active CE IVDR CE IVDD EUDAMEDGUDID II
SARS-CoV-2 IgA AccuBind ELISA Test System - 96 Wells 11825-300

Monobind, Inc.,United States Not classified

Active CE IVDD EUDAMEDGUDID —
AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 192 Wells 8525-300

Monobind, Inc.,United States Class II

Active CE IVDD EUDAMEDGUDID II
Liofilchem MTS (MIC Test Strip) UDI-DI 08055182872558

Liofilchem, Inc.,United States(FDA 510(k) applicant) Class II

Active CE IVDR EUDAMEDGUDID II
21 variants
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T3 AccuLite CLIA Test System - 96 Wells 175-300

Monobind, Inc.,United States Class II

Active CE IVDD EUDAMEDGUDID II
ANCA Test System 10350-11

Immuno Concepts Inc,United States(FDA 510(k) applicant) Not classified

Active CE IVDD EUDAMEDGUDID —
HEp-2000® IgG Fluorescent ANA-Ro Test System 2075G-Ro (1)

Immuno Concepts Inc,United States(FDA 510(k) applicant) Not classified

Active CE IVDD EUDAMEDGUDID —
Endoret® Test-Tube Rack With Cover For Transport Gtt

Biotechnology Institute Sl,FDA registration: United States Class I

Active CE MDR EUDAMEDGUDID I
Fluorescent nDNA Test System 2004-14

Immuno Concepts Inc,United States(FDA 510(k) applicant) Not classified

Active CE IVDD EUDAMEDGUDID —
ADVIA® 120/2120/2120i 3-in-1 TESTpoint Normal Control 10316217

Siemens Healthcare Diagnostics Inc.,United States Class II

Active CE IVDR EUDAMEDGUDID II
LTA Check Test Kit 107117

Bio/Data Corporation,United States Class I

Active CE IVDR EUDAMEDGUDID I
T3 SBS AccuLite CLIA Test System - 96 Wells 8175-300

Monobind, Inc.,United States Class II

Active CE IVDD EUDAMEDGUDID II
Prolex Staph Kit (300 Tests) PL.081B

Pro-Lab, Incorporated,FDA registration: Canada Class I

Active CE IVDD EUDAMEDGUDID I

Results for “TEST”

Category (EMDN)

SHBG AccuBind ELISA Test System - 192 Wells 9125-300

IgG Anti-nDNA Fluorescent Test System 3005G

HEp-2000® IgG Fluorescent ANA-Ro Test System 8400CS-Ro

DHEA AccuLite CLIA Test System - 192 Wells 7475-300

Fluorescent ANA Test System 8021.1

RELISA® Cardiolipin IgG & IgM Antibody Test 8192

Histofluor® Rodent LKS Fluorescent Antibody Test System 12160-04

CEA AccuBind ELISA Test System - 192 Wells 1825-300

SARS-CoV-2 IgA AccuBind ELISA Test System - 96 Wells 11825-300

AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 192 Wells 8525-300

Liofilchem MTS (MIC Test Strip) UDI-DI 08055182872558

T3 AccuLite CLIA Test System - 96 Wells 175-300

ANCA Test System 10350-11

HEp-2000® IgG Fluorescent ANA-Ro Test System 2075G-Ro (1)

Endoret® Test-Tube Rack With Cover For Transport Gtt

Fluorescent nDNA Test System 2004-14

ADVIA® 120/2120/2120i 3-in-1 TESTpoint Normal Control 10316217

LTA Check Test Kit 107117

T3 SBS AccuLite CLIA Test System - 96 Wells 8175-300

Prolex Staph Kit (300 Tests) PL.081B