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Liofilchem MTS (MIC Test Strip) UDI-DI 08055182870240

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

Active CE IVDR EUDAMEDGUDID II
21 variants
- See all variants of this device
FREND Testosterone FRTE-HB

NanoEnTek, Inc.,South Korea Class I

Active CE IVDD EUDAMEDGUDID I
Calcitonin AccuBind ELISA Test System - 96 Wells 9325-300

Monobind, Inc.,United States Class II

Active CE IVDD EUDAMEDGUDID II
uE3 AccuLite CLIA Test System - 96 Wells 5075-300

Monobind, Inc.,United States Class I

Active CE IVDD EUDAMEDGUDID I
HEp-2000® IgG Fluorescent ANA-Ro Test System 2004G-21-Ro

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

Active CE IVDD EUDAMEDGUDID —
CLINITEST® hCG Pregnancy Test 10310618

Siemens Healthcare Diagnostics Inc.,United States Class II

Expiring CE IVDR EUDAMEDGUDID II
T3 AccuLite CLIA Test System - 960 Wells 175-300

Monobind, Inc.,United States Class II

Active CE IVDD EUDAMEDGUDID II
Free B-hCG XR AccuBind ELISA Test System - 192 Wells 2025-300

Monobind, Inc.,United States Class II

Active CE IVDD EUDAMEDGUDID II
BioHermes Glycohemoglobin Test Kit GLU-A1C S03

Wuxi Biohermes Bio & Medical Technology Co., Ltd.,FDA registration: United States Not classified

Active CE IVDD EUDAMEDGUDID —
Disposable infusion sleeve for 2.8 mm phaco needle including test chamber. 3009.IRD28

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

Active CE MDD EUDAMEDGUDID II
Colorzyme® ANA Test System 4075 (1)

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

Active CE IVDD EUDAMEDGUDID —
17OHP AccuBind ELISA Test System - 96 Wells 5225-300

Monobind, Inc.,United States Class I

Active CE IVDD EUDAMEDGUDID I
Tg AccuLite CLIA Test System - 192 Wells 2275-300

Monobind, Inc.,United States Class II

Active CE IVDR CE IVDD EUDAMEDGUDID II
T4 AccuLite CLIA Test System - 960 Wells 275-300

Monobind, Inc.,United States Class II

Active CE IVDD EUDAMEDGUDID II
PRL AccuBind ELISA Test System - 192 Wells 725-300

Monobind, Inc.,United States Class I

Active CE IVDD EUDAMEDGUDID I
Maico Pilot Test

MAICO Diagnostics GmbH,FDA registration: Germany Class II

Active CE MDR EUDAMEDGUDID II
BioHermes GluCoA1c Blood Glucose Test Strips GLU-A1C S06

Wuxi Biohermes Bio & Medical Technology Co., Ltd.,FDA registration: United States Not classified

Active CE IVDD EUDAMEDGUDID —
HEp-2000® IgG Fluorescent ANA-Ro Test System 8270-Ro

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

Active CE IVDD EUDAMEDGUDID —
HEp-2000® Fluorescent ANA-Ro Test System 2026 (1)

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

Active CE IVDD EUDAMEDGUDID —
AFP, hCG, uE3 Triple Screen Panel AccuLite VAST CLIA Test System - 96 Wells 8575-300

Monobind, Inc.,United States Class II

Active CE IVDD EUDAMEDGUDID II

Results for “TEST”

Category (EMDN)

Liofilchem MTS (MIC Test Strip) UDI-DI 08055182870240

FREND Testosterone FRTE-HB

Calcitonin AccuBind ELISA Test System - 96 Wells 9325-300

uE3 AccuLite CLIA Test System - 96 Wells 5075-300

HEp-2000® IgG Fluorescent ANA-Ro Test System 2004G-21-Ro

CLINITEST® hCG Pregnancy Test 10310618

T3 AccuLite CLIA Test System - 960 Wells 175-300

Free B-hCG XR AccuBind ELISA Test System - 192 Wells 2025-300

BioHermes Glycohemoglobin Test Kit GLU-A1C S03

Disposable infusion sleeve for 2.8 mm phaco needle including test chamber. 3009.IRD28

Colorzyme® ANA Test System 4075 (1)

17OHP AccuBind ELISA Test System - 96 Wells 5225-300

Tg AccuLite CLIA Test System - 192 Wells 2275-300

T4 AccuLite CLIA Test System - 960 Wells 275-300

PRL AccuBind ELISA Test System - 192 Wells 725-300

Maico Pilot Test

BioHermes GluCoA1c Blood Glucose Test Strips GLU-A1C S06

HEp-2000® IgG Fluorescent ANA-Ro Test System 8270-Ro

HEp-2000® Fluorescent ANA-Ro Test System 2026 (1)

AFP, hCG, uE3 Triple Screen Panel AccuLite VAST CLIA Test System - 96 Wells 8575-300