VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Atlas HCG Latex Reagent, 2 ml/Vial, Individually Packed, 1 Vial /Box.

Device

EU IVDD · Eu Ivd General ·Atlas Medical GmbH·On the market

Atlas HCG Latex Reagent, 4 ml/Vial, Individually Packed, 1 Vial /Box.

Device

EU IVDD · Eu Ivd General ·Atlas Medical GmbH·On the market

Free Beta-Human Chorionic Gonadotropin (Free β-HCG) Assay Reagent Kit (CMIA)

Device

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

Free Beta-Human Chorionic Gonadotropin (Free β-HCG) Assay Reagent Kit (CMIA)

Device

EU IVDD · Eu Ivd General ·Hangzhou Cybereagen Biotech Co., Ltd.·On the market

Total Beta subunit of human chorionic gonadotropin (β-HCG) Detection Kit(CLIA)

Device

EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·On the market

Beta Subunit of Human Chorionic Gonadotropin (β-HCG) Detection Kit(Fluorescence Immunoassay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·On the market

HCG/β-HCG (CLIA)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Shenzhen New Industries Biomedical Engineering Co., Ltd.·1 device

Alinity i Total ß-hCG Reagent Kit, Alinity i System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Alinity i Total ß-hCG Reagent Kit, GLP systems Track

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Free β-subunit of human chorionic gonadotropin(free β-HCG) Detection Kit(CLIA)

Device

EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·On the market

EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EZ SURE URINE DIPSTICK PREGNANCY HOME TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry