5 results
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7ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Iii
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CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.
FDA Enforcement
Class III
·Terminated·Biochemical Diagnostics Inc·December 2, 2015
Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early detection of pregnancy. This test is for professional use.
FDA Enforcement
Class III
·Terminated·Alere San Diego, Inc.·May 29, 2013
Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests such as K-CHECK and Ictotest reagent tablets, and for hCG methods.
FDA Enforcement
Class III
·Terminated·Quantimetrix Corporation·June 27, 2018
ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP Prolactin assay: For in vitro diagnostic use in the quantitative determination of prolactin in serum using the ADVIA Centaur System. ADVIA Centaur Calibrator B: For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur¿ Systems: Digoxin, FSH, TotallgE, LH, LH2, Prolactin, Total hCG, and TSH
FDA Enforcement
Class III
·Terminated·Siemens Healthcare Diagnostics, Inc·September 26, 2012
Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169-112, BD PYXIS MEDBANK MINI 3HH-1HM/169-111, BD PYXIS MEDBANK MINI 3HH-1FG/169-110, BD PYXIS MEDBANK MINI 2HM-1FM/169-109, BD PYXIS MEDBANK MINI 2HH-2HM/169-108, BD PYXIS MEDBANK MINI 2HH-1FM/169-107, BD PYXIS MEDBANK MINI 2HH-1FH/169-106, BD PYXIS MEDBANK MINI 2FM/169-105, BD PYXIS MEDBANK MINI 2FH/169-104, BD PYXIS MEDBANK MINI 1HH-3HM/169-103, BD PYXIS MEDBANK MINI 1HH-1HM-1FM/169-102, BD PYXIS MEDBANK MINI 1HH-1FH-1HM/169-101 , BD PYXIS MEDBANK MINI 1FH-2HH/155311-01, BD PYXIS MEDBANK MINI 4HH/155310-01, BD PYXIS MEDBANK MINI 1FH-1FM/155288-01, BD PYXIS MEDBANK MINI 4HM/155171-01, BD PYXIS MEDBANK MINI 3HH-1HM/155169-01, BD PYXIS MEDBANK MINI 3HH-1FG/155168-01, BD PYXIS MEDBANK MINI 2HM-1FM/155167-01, BD PYXIS MEDBANK MINI 2HH-2HM/155166-01, BD PYXIS MEDBANK MINI 2HH-1FM/155165-01, BD PYXIS MEDBANK MINI 2FM/155163-01, BD PYXIS MEDBANK MINI 1HH-3HM/155161-01, BD PYXIS MEDBANK MINI 1HH-1HM-1FM/155160-01, BD PYXIS MEDBANK MINI 1HH-1FH-1HM/155159-01, BD PYXIS MEDBANK MINI 2HM-1FM/139131-01, BD PYXIS MEDBANK MINI 1HH-1HM-1FM/139122-01, BD PYXIS MEDBANK MINI 3HH-1FG/139091-01, BD PYXIS MEDBANK MINI 1HH-1FH-1HM/138921-01, BD PYXIS MEDBANK MINI 4HM/138915-01, BD PYXIS MEDBANK MINI 1HH-3HM/138912-01, BD PYXIS MEDBANK MINI 4HH/138910-01, BD PYXIS MEDBANK MINI 3HH-1HM/138909-01, BD PYXIS MEDBANK MINI 2HH-1FH/138908-01, BD PYXIS MEDBANK MINI 2HH-2HM/138907-01, BD PYXIS MEDBANK MINI 2HH-1FM/138906-01, BD PYXIS MEDBANK MINI 2FM/138903-01, BD PYXIS MEDBANK MINI 2FH/138902-01, MEDBANK MINI MAIN/1147-00, MEDBANK MAIN/1137-00, BD PYXIS MEDBANK TWR MN 8HH-3FM/169-81, BD PYXIS MEDBANK TWR MN 8HH-3FH/169-80, BD PYXIS MEDBANK TWR MN 8HH-3FF/169-79, BD PYXIS MEDBANK TWR MN 8HH-2HM-2FM/169-78, BD PYXIS MEDBANK TWR MN 8HH-2FH-1FM/169-77, BD PYXIS MEDBANK TWR MN 8HH-1FH-2HM-1FM/169-76, BD PYXIS MEDBANK TWR MN 8HH-1FH-2FM/169-75, BD PYXIS MEDBANK TWR MN 7HH-1HM-3FM/169-74, BD PYXIS MEDBANK TWR MN 7FM/169-73, BD PYXIS MEDBANK TWR MN 7FH/169-72, BD PYXIS MEDBANK TWR MN 6HH-8HM/169-71, BD PYXIS MEDBANK TWR MN 6HH-6HM-1FM/169-70, BD PYXIS MEDBANK TWR MN 6HH-4HM-2FM/169-69, BD PYXIS MEDBANK TWR MN 6HH-4FM/169-68, BD PYXIS MEDBANK TWR MN 6HH-4FH /169-67, BD PYXIS MEDBANK TWR MN 6HH-2FH-2HM-1FM/169-66, BD PYXIS MEDBANK TWR MN 6HH-2FH-2FM/169-65, BD PYXIS MEDBANK TWR MN 6HH-1FH-3FM/169-64, BD PYXIS MEDBANK TWR MN 6HH-1FH-2HM-2FM/169-63, BD PYXIS MEDBANK TWR MN 6FH-1FM/169-62, BD PYXIS MEDBANK TWR MN 5HH-9HM/169-61, BD PYXIS MEDBANK TWR MN 5HH-3HM-3FM/169-60, BD PYXIS MEDBANK TWR MN 4HM-5FM/169-59, BD PYXIS MEDBANK TWR MN 4HH-8HM-1FM/169-58, BD PYXIS MEDBANK TWR MN 4HH-6HM-2FM/169-57, BD PYXIS MEDBANK TWR MN 4HH-5FM/169-56, BD PYXIS MEDBANK TWR MN 4HH-5FH /169-55, BD PYXIS MEDBANK TWR MN 4HH-4HM-3FM/169-54, BD PYXIS MEDBANK TWR MN 4HH-4FH-1FM/169-53, BD PYXIS MEDBANK TWR MN 4HH-3FH-2FM/169-52, BD PYXIS MEDBANK TWR MN 4HH-2HM-4FM/169-51, BD PYXIS MEDBANK TWR MN 4HH-2FH-3FM/169-50, BD PYXIS MEDBANK TWR MN 4HH-2FH-2HM-2FM/169-49, BD PYXIS MEDBANK TWR MN 4HH-1FH-6HM-1FM/169-48, BD PYXIS MEDBANK TWR MN 4HH-1FH-4HM-2FM/169-47, BD PYXIS MEDBANK TWR MN 4HH-1FH-4FM/169-46, BD PYXIS MEDBANK TWR MN 4HH-1FH-2HM-3FM/169-45, BD PYXIS MEDBANK TWR MN 4HH-10HM/169-44, BD PYXIS MEDBANK TWR MN 3HH-7HM-2FM/169-43, BD PYXIS MEDBANK TWR MN 3FH-4FM/169-42, BD PYXIS MEDBANK TWR MN 2HM-6FM/169-41, BD PYXIS MEDBANK TWR MN 2HH-8HM-2FM/169-40, BD PYXIS MEDBANK TWR MN 2HH-6HM-3FM/169-39, BD PYXIS MEDBANK TWR MN 2HH-6FM/169-38, BD PYXIS MEDBANK TWR MN 2HH-4HM-4FM/169-37, BD PYXIS MEDBANK TWR MN 2HH-4HM-4FF/169-36, BD PYXIS MEDBANK TWR MN 2HH-2FM-4FF/169-35, BD PYXIS MEDBANK TWR MN 2HH-2FH-4FM/169-34, BD PYXIS MEDBANK TWR MN 2HH-1FH-5FM/169-33, BD PYXIS MEDBANK TWR MN 2HH-10HM-1FM/169-32, BD PY
FDA Enforcement
Class III
·Ongoing·CareFusion 303, Inc.·August 20, 2025