103 results
·
15ms
·
Sources: EU EUDAMED, US FDA
AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
FDA Enforcement
Class II
·Ongoing·PerkinElmer Life and Analytical Sciences, Wallac, OY·May 8, 2019
AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
FDA Enforcement
Class II
·Ongoing·PerkinElmer Life and Analytical Sciences, Wallac, OY·May 8, 2019
DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.
FDA Enforcement
Class II
·Ongoing·PerkinElmer Life and Analytical Sciences, Wallac, OY·May 8, 2019
COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G57682; Reference Part Number C-PTIS-100-UNL-HC-G-EU, Order Number G57687; Reference Part Number C-PTIS-100-UNS-HC-G-EU, Order Number G57686.
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·April 15, 2026
COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704.
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·April 15, 2026
a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210. b. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere hCG Dipstick Fertility Test hCG Pregnancy Test Urine Sample 50 Tests Model Number: 92211.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022
a. McKesson Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Serum / Urine Sample 25 Tests. Model Number: 5002. b. McKesson Consult Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Urine Sample 25 Tests Model Number: 5000. c. McKesson Medical-Surgical McKesson TEST KIT, PREG HCG CASSETTE WAIVED Model Number: 5001
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022
Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. Model/Catalog Number: 1004
FDA Enforcement
Class II
·Ongoing·Princeton Biomeditech Corp·November 6, 2024
SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
Lem Fertility hCG Pregnancy Urine Test REF 100-12
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01
FDA Enforcement
Class II
·Ongoing·Biomerieux Inc·January 11, 2023
PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
Am I Pregnant? One Step HCG Pregnancy Test REF 100-17
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/ 169-101, MEDBANK MINI 1HH-1HM-1FM/ 169-102, MEDBANK MINI 1HH-3HM/ 169-103, MEDBANK MINI 2FH/ 169-104, MEDBANK MINI 2FM/ 169-105, MEDBANK MINI 2HH-1FH/ 169-106, MEDBANK MINI 2HH-1FM/ 169-107, MEDBANK MINI 2HH-1FM MEDPASS/ 169-152, MEDBANK MINI 2HH-2HM/ 169-108, MEDBANK MINI 2HM-1FM/ 169-109, MEDBANK MINI 3HH-1FG/ 169-110, MEDBANK MINI 3HH-1HM/ 169-111, MEDBANK MINI 4HH/ 169-112, MEDBANK MINI 4HH MEDPASS/ 169-150, MEDBANK MINI 4HM/ 169-113, MEDBANK MINI CR-2HH-1FH-P/ 169-114, MEDBANK MINI CR-4HH-P/ 169-115, MB MINI MAIN CR/ 169-163, MB MINI MAIN W/CUBIE DRWS/ 169-159, MB MINI MAIN W/FH FALSE DRW/ 169-162, MB MINI MAIN W/HH FALSE DRW/ 169-161, MB MINI MAIN W/MATRIX DRWS / 169-160, MB MINI MAIN W/MP/ 169-164 Used with the following user guides: BD Pyxis CUBIE Replenishment Station User Guide (DIR 10000414989), BD Pyxis MedBank Cabinet User Guide (DIR 10000414987), BD Pyxis MedBank Installation and Upgrade Guide (DIR 10000414990)
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·July 10, 2024
IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·May 4, 2022