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Radioimmunoassay, Luteinizing Hormone
FDA product code CEP · Class 1 · Clinical Chemistry
148
Registered devices
74
Adverse events
6
Recalls
143
510(k) clearances
Devices with this code
Easy@Home Ovulation Test Strip (50 tests-bulk pack) — EASY HEALTHCARE CORPORATIONDr. Talbot's — TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLCCVS Health — WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDEasy@Home Ovulation Test (100 LH strips) — EASY HEALTHCARE CORPORATIONACCUHOME OVULATION — GERMAINE LABORATORIES, INCEquate — WAL-MART STORES, INC.CVS Health — WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDHealthyWiser LLC — HEALTHYWISER LLCIMMULITE 2000 LH Kt Domestic 600T — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDPremom Ovulation Test Kit (60 LH + 20 HCG) — EASY HEALTHCARE CORPORATIONEasy@Home Ovulation Test kit (100 LH strips + 20 HCG strips ) — EASY HEALTHCARE CORPORATIONVITROS — ORTHO CLINICAL DIAGNOSTICSLH AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.Easy@Home Disposable Plastic Urine Specimen Cups (50- pack) — EASY HEALTHCARE CORPORATIONAccuDiag™ LH ELISA — Diagnostic Automation, Inc.IMMULITE® 2000 Systems LH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDThe Babydust Method — BABYDUST METHOD LLC, THEExchange Select — SPD SWISS PRECISION DIAGNOSTICS GMBHAIMSTEP OVULATION — GERMAINE LABORATORIES, INCCVS Health — WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDPremom Ovulation Test Cassette (25 test kit) — EASY HEALTHCARE CORPORATIONQMedix™ — Diagnostic Automation, Inc.LH-Urine ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungEasy@Home Ovulation Test Strip (25 tests kit) — EASY HEALTHCARE CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-03-25 | Ortho-Clinical Diagnostics, Inc | Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecis |
| 2021-09-22 | bioMerieux, Inc. | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote |
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, dependin |
| 2012-11-05 | Beckman Coulter Inc. | Beckman Coulter Inc. (BEC) has demonstrated that real time stability testing of hLH Calibrator of certain lots have failed the 13-month and 14-month time points |
| 2006-11-22 | Abbott Laboratories MPG | The lots of ARCHITECT LH Reagent List 6C25-22, have the potential to generate patient specimen results that are elevated. Correlation studies have demonstrated |
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