Face shield

FDA registration

HENGSHUI GANGSHENG MEDICAL INSTRUMENTS CO., LTD·1 product·🇨🇳 China

Mask

FDA registration

Hubei Yi-Ya Protective Products Co., Ltd.·1 product·🇨🇳 China

Pregmate 50 Ovulation and 20 Pregnancy Test Strips

FDA UDI

Pregmate LLC·00850009763150·

Performance Check Dye Kit

FDA UDI

Gold Standard Diagnostics Corporation·B350GSD0124500·Performance Check Dye Kit

ThunderBolt EIA (CLIA)

FDA UDI

Gold Standard Diagnostics Corporation·B35000300CLR0·ThunderBolt EIA-CLIA (refurbished)

Trinity Biotech

FDA UDI

MARDX DIAGNOSTICS, INC.·05391516747844·HEp-2 Marblot Strip Test System, Western Blot S...

ThunderBolt EIA (CLIA)

FDA UDI

Gold Standard Diagnostics Corporation·B35000300CL0·ThunderBolt EIA-CLIA

Bolt (CLIA)

FDA UDI

Gold Standard Diagnostics Corporation·B35000500CLR0·Bolt EIA-CLIA (refurbished)

Bolt (CLIA)

FDA UDI

Gold Standard Diagnostics Corporation·B35000500CL0·Bolt EIA-CLIA

DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA

FDA 510(k)

FDA Class 2 ·Immunology

ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads

FDA 510(k)

FDA Class 2 ·Orthopedic

ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35

FDA 510(k)

FDA Class 2 ·Immunology

AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200

FDA 510(k)

FDA Class 2 ·Immunology

VAPAMASTA 6

FDA 510(k)

FDA Class 2 ·Anesthesiology

AXIS-SHIELD ACVTIVE-B12

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HAWK ANAESTHESIA INDUCTION UNIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10

FDA 510(k)

FDA Class 2 ·Clinical Chemistry