Medical Device Catalogue

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ANCA Test System 10350-12

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

Active CE IVDD EUDAMEDGUDID —
GEM Premier 3500 3000 iQM BG HCT PAK (35 TEST) 00026403584

Instrumentation Laboratory Company,United States Class II

Active CE IVDR EUDAMEDGUDID II
Fluorescent nDNA Test System 3007 (10)

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

Active CE IVDD EUDAMEDGUDID —
GEM Premier 3500 3000 iQM BG LYTES GL (75 TEST) 00026307589

Instrumentation Laboratory Company,United States Class II

Active CE IVDR EUDAMEDGUDID II
HEp-2000® IgG Fluorescent ANA-Ro Test System 2140G-Ro

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

Active CE IVDD EUDAMEDGUDID —
PTH Whole & Intact AccuLite VAST CLIA Test System - 192 Wells 10075-300

Monobind, Inc.,United States Class II

Active CE IVDD EUDAMEDGUDID II
Histofluor® Rodent LKS Fluorescent Antibody Test System 12004-03 (10)

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

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

Alere San Diego, Inc.,United States Class II

Active CE IVDD EUDAMEDGUDID II
Histofluor® Rodent LKS Fluorescent Antibody Test System 12160-02

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

Active CE IVDD EUDAMEDGUDID —
Histofluor® IgA Fluorescent Antibody Test System 12009-01 (1)

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

Active CE IVDD EUDAMEDGUDID —
GEM Premier 3500 3000 iQM BG LYTES (75 TEST) 00026407587

Instrumentation Laboratory Company,United States Class II

Active CE IVDR EUDAMEDGUDID II
N-17-OHP AccuBind ELISA Test System - 96 Wells 5525-300

Monobind, Inc.,United States Class I

Active CE IVDD EUDAMEDGUDID I
T3, T4, TSH Thyroid Panel AccuBind VASTAccuBind ELISA Test System - 480 Wells 8025-300

Monobind, Inc.,United States Class II

Active CE IVDD EUDAMEDGUDID II
AMH AccuLite CLIA Test System - 192 Wells 9775-300

Monobind, Inc.,United States Class II

Active CE IVDD EUDAMEDGUDID II
GEM Premier 3500 3000 iQM BG LYTES GL (600 TEST) 00026360089

Instrumentation Laboratory Company,United States Class II

Active CE IVDR EUDAMEDGUDID II
Disposable infusion sleeve for 2.2 mm phaco needle Including test chamber 3008.IRD22

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.,FDA registration: United States Class II

Active CE MDD EUDAMEDGUDID II
TSH AccuLite CLIA Test System - 960 Wells 375-300

Monobind, Inc.,United States Class II

Active CE IVDD EUDAMEDGUDID II
Liofilchem MTS (MIC Test Strip) Imipenem IMI 0.016-256 100 MTS canister

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

Active CE IVDR EUDAMEDGUDID II
Sentimag SMC02 Probe Test Phantom

Endomagnetics Ltd,United Kingdom Class III

Active CE MDR EUDAMEDGUDID III
Fluorescent ANA Test System 100

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

Active CE IVDD EUDAMEDGUDID —

Results for “TEST”

Category (EMDN)

ANCA Test System 10350-12

GEM Premier 3500 3000 iQM BG HCT PAK (35 TEST) 00026403584

Fluorescent nDNA Test System 3007 (10)

GEM Premier 3500 3000 iQM BG LYTES GL (75 TEST) 00026307589

HEp-2000® IgG Fluorescent ANA-Ro Test System 2140G-Ro

PTH Whole & Intact AccuLite VAST CLIA Test System - 192 Wells 10075-300

Histofluor® Rodent LKS Fluorescent Antibody Test System 12004-03 (10)

SureStep™ Urine Test Drug Screen Strip DBZ-101

Histofluor® Rodent LKS Fluorescent Antibody Test System 12160-02

Histofluor® IgA Fluorescent Antibody Test System 12009-01 (1)

GEM Premier 3500 3000 iQM BG LYTES (75 TEST) 00026407587

N-17-OHP AccuBind ELISA Test System - 96 Wells 5525-300

T3, T4, TSH Thyroid Panel AccuBind VASTAccuBind ELISA Test System - 480 Wells 8025-300

AMH AccuLite CLIA Test System - 192 Wells 9775-300

GEM Premier 3500 3000 iQM BG LYTES GL (600 TEST) 00026360089

Disposable infusion sleeve for 2.2 mm phaco needle Including test chamber 3008.IRD22

TSH AccuLite CLIA Test System - 960 Wells 375-300

Liofilchem MTS (MIC Test Strip) Imipenem IMI 0.016-256 100 MTS canister

Sentimag SMC02 Probe Test Phantom

Fluorescent ANA Test System 100