Medical Device Catalogue

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Colorzyme® ANA Test System 4200

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

Active CE IVDD EUDAMEDGUDID —
T3 Uptake AccuBind ELISA Test System - 96 Wells 525-300

Monobind, Inc.,United States Class II

Active CE IVDD EUDAMEDGUDID II
Histofluor® Rodent LKS Fluorescent Antibody Test System 12080-03

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

Active CE IVDD EUDAMEDGUDID —
Free T3 AccuBind ELISA Test System - 960 Wells 1325-300

Monobind, Inc.,United States Class II

Active CE IVDD EUDAMEDGUDID II
Testosterone AccuLite CLIA Test System - 96 Wells 3775-300

Monobind, Inc.,United States Class I

Active CE IVDD EUDAMEDGUDID I
IgG Anti-nDNA Fluorescent Test System 3200G

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

Active CE IVDD EUDAMEDGUDID —
HEp-2000® Fluorescent ANA-Ro Test System 2041 (1)

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

Active CE IVDD EUDAMEDGUDID —
Free B-hCG XR AccuBind ELISA Test System - 96 Wells 2025-300

Monobind, Inc.,United States Class II

Active CE IVDD EUDAMEDGUDID II
C-Peptide & Insulin Diabetes Panel AccuLite VAST CLIA Test System - 192 Wells 7375-300

Monobind, Inc.,United States Class I

Active CE IVDD EUDAMEDGUDID I
PRL AccuLite CLIA Test System - 192 Wells 775-300

Monobind, Inc.,United States Class I

Active CE IVDD EUDAMEDGUDID I
HEp-2000® Fluorescent ANA-Ro Test System

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

Active CE IVDD EUDAMEDGUDID —
Histofluor® IgG Fluorescent Antibody Test System 12009-10 (1)

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

Active CE IVDD EUDAMEDGUDID —
Fluorescent ANA Test System 1000

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

Active CE IVDD EUDAMEDGUDID —
Cortisol AccuBind ELISA Test System - 96 Wells 3625-300

Monobind, Inc.,United States Class II

Active CE IVDD EUDAMEDGUDID II
Epoc Bgem Bun Test Card 10736515

Epocal Inc,Canada Not classified

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

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

Active CE IVDD EUDAMEDGUDID —
RELISA® Cardiolipin IgG & IgM Antibody Test 7096-02

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

Active CE IVDD EUDAMEDGUDID —
SureStep™ Urine Test Drug Screen Strip DMT-101

Alere San Diego, Inc.,United States Class II

Active CE IVDD EUDAMEDGUDID II
D-Dimer AccuBind ELISA Test System - 192 Wells 12025-300

Monobind, Inc.,United States Class II

Active CE IVDD EUDAMEDGUDID II
Colorzyme® nDNA Test System 5200

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

Active CE IVDD EUDAMEDGUDID —

Results for “TEST”

Category (EMDN)

Colorzyme® ANA Test System 4200

T3 Uptake AccuBind ELISA Test System - 96 Wells 525-300

Histofluor® Rodent LKS Fluorescent Antibody Test System 12080-03

Free T3 AccuBind ELISA Test System - 960 Wells 1325-300

Testosterone AccuLite CLIA Test System - 96 Wells 3775-300

IgG Anti-nDNA Fluorescent Test System 3200G

HEp-2000® Fluorescent ANA-Ro Test System 2041 (1)

Free B-hCG XR AccuBind ELISA Test System - 96 Wells 2025-300

C-Peptide & Insulin Diabetes Panel AccuLite VAST CLIA Test System - 192 Wells 7375-300

PRL AccuLite CLIA Test System - 192 Wells 775-300

HEp-2000® Fluorescent ANA-Ro Test System

Histofluor® IgG Fluorescent Antibody Test System 12009-10 (1)

Fluorescent ANA Test System 1000

Cortisol AccuBind ELISA Test System - 96 Wells 3625-300

Epoc Bgem Bun Test Card 10736515

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

RELISA® Cardiolipin IgG & IgM Antibody Test 7096-02

SureStep™ Urine Test Drug Screen Strip DMT-101

D-Dimer AccuBind ELISA Test System - 192 Wells 12025-300

Colorzyme® nDNA Test System 5200