CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS

Device

EU IVDD · Eu Ivd Annex 2 List B ·Daan Gene Co., Ltd.·On the market

SARS-Cov-2＆Influenza A/B Combo Rapid Test Cassette (swab)

Device

EU IVDD · Eu Ivd Self Testing ·Hangzhou Realy Tech Co.,Ltd.·On the market

Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab)

Device

EU IVDD · Eu Ivd Self Testing ·Hangzhou Realy Tech Co.,Ltd.·On the market

VIROLOGY - RT & POC - OTHER

Device

EU IVDD · Eu Ivd Self Testing ·Zhongshan Bio-Tech Co., Ltd.·On the market

VIROLOGY - RT & POC - OTHER

Device

EU IVDD · Eu Ivd Self Testing ·Zhongshan Bio-Tech Co., Ltd.·On the market

CORONAVIRUS [obsolete from 2025-01-01]

Device

EU IVDD · Eu Ivd Self Testing ·Dynamiker Biotechnology (Tianjin) Co., Ltd.·On the market

Novel Coronavirus（SARS-Cov-2）Antigen Rapid Test Device（saliva）

Device

EU IVDD · Eu Ivd Self Testing ·Hangzhou Realy Tech Co.,Ltd.·On the market

SARS-CoV-2 Antigen Rapid Test Cassette

Device

EU IVDD · Eu Ivd Self Testing ·Merlin Biomedical (Xiamen) Co., Ltd.·On the market

AMT Initial Placement Kit

FDA UDI

APPLIED MEDICAL TECHNOLOGY, INC.·00842071131432·AMT Initial Placement Kit with Sheaths (12-18FR)

AMT Initial Placement Kit

FDA UDI

APPLIED MEDICAL TECHNOLOGY, INC.·00842071131425·AMT Initial Placement Kit (12-18FR)

Iron Intern

FDA UDI

Automated Medical Products Corp.·00810118340970·GFO 82 Giant "Sweetlips" with Fiber-optic

Stat Profile

FDA UDI

NOVA BIOMEDICAL CORPORATION·00385480563079·Prime Carousel Tray

OratectCheck Oral Fluid Controls

FDA UDI

BRANAN MEDICAL CORPORATION·00816555020222·Positive and Negative Oral Fluid Controls

Carolina Liquid Chemistries Corp. Basic Multi-Drug Control Set

FDA UDI

CAROLINA LIQUID CHEMISTRIES CORPORATION·00817302022353·

DRUGS OF ABUSE LOW

FDA UDI

UTAK LABORATORIES, INC.·B800DALOWV2WBFBTL0·DRUGS OF ABUSE LOW

DRUGS OF ABUSE B LEVEL 1

FDA UDI

UTAK LABORATORIES, INC.·B800DAUB1FBCPC0·DRUGS OF ABUSE B LEVEL 1

SALIVABUSE

FDA UDI

BIOCHEMICAL DIAGNOSTICS INC·00810042682658·ORAL-SKREEN, 3X Cutoff, 6x20mL

Mission Plus Hemoglobin (Hb) Optical Verifier

FDA UDI

ACON LABORATORIES, INC.·00682607000203·Vial of 2 Optical Verifiers

My Yodoc

FDA UDI

S-CONNECT CO.,LTD·08800068200006·

METHAMPHETAMINES CALIBRATOR 1

FDA UDI

UTAK LABORATORIES, INC.·B800METHCAL1UIMMU0·METHAMPHETAMINES CALIBRATOR 1