Rapid Response

FDA UDI

BTNX Inc·00722066001936·Urine Analyzer 120

Moore Medical

FDA UDI

MOORE MEDICAL LLC·10607415002055·U120 Smaller Analyzer

Azostix® Reagent Strips

FDA UDI

Siemens Healthcare Diagnostics Inc.·00630414551142·AZOSTIX® is a firm, plastic strip to which is a...

Hema-Combistix® Reagent Strips

FDA UDI

Siemens Healthcare Diagnostics Inc.·00630414549118·Siemens Healthcare Diagnostics Reagent Strips f...

Uristix® 4 Reagent Strips

FDA UDI

Siemens Healthcare Diagnostics Inc.·00630414549057·Siemens Healthcare Diagnostics Reagent Strips f...

Multistix PRO® 10LS Reagent Strips

FDA UDI

Siemens Healthcare Diagnostics Inc.·00630414549255·Siemens Healthcare Diagnostics MULTISTIX PRO® 1...

AUTION™ Sticks 10EA Test Strips

FDA UDI

ARKRAY USA, INC.·00015482735265·Test Sticks for the determination of Glucose, P...

Multistix® 9 Reagent Strips

FDA UDI

Siemens Healthcare Diagnostics Inc.·00630414549019·Siemens Healthcare Diagnostics Reagent Strips f...

AIMSTRIP US-11

FDA UDI

GERMAINE LABORATORIES, INC·00695684511111·

AUTION™ MAX AX-4022 Analyzer

FDA UDI

ARKRAY USA, INC.·00015482129743·Urine Analyzer utilize reflectance technology w...

QTEST™ 11

FDA UDI

DFI CO.,LTD·08806141301479·The one device that has DI number included 100 ...

CONTEC

FDA UDI

Contec Medical Systems Co., Ltd.·06945040104780·Urinalysis Strips

StatConsult IT-Service GmbH

System producer

🇩🇪 Germany

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR

GERMAINE LABORATORIES, INC.

FDA registration

GERMAINE LABORATORIES, INC.·12 products·🇺🇸 United States

EUROMEDISHOP

FDA registration

EUROMEDISHOP·13 products·🇫🇷 France

Mission U500 Urine Analyzer

FDA registration

ACON LABORATORIES, INC.·12 products·🇺🇸 United States

MACHEREY-NAGEL GMBH & CO., KG.

FDA registration

MACHEREY-NAGEL GMBH & CO., KG.·12 products·🇩🇪 Germany

Clinitek Status+

FDA registration

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD·13 products·🇬🇧 United Kingdom

Mission U500 Urine Analyzer

FDA registration

ACON BIOTECH (HANGZHOU) CO., LTD.·12 products·🇨🇳 China