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Radioimmunoassay, Luteinizing Hormone
FDA product code CEP · Class 1 · Clinical Chemistry
149
Registered devices
74
Adverse events
6
Recalls
143
510(k) clearances
Devices with this code
HealthyWiser LLC — HEALTHYWISER LLCH.E.B — H. E. BUTT GROCERY COMPANYGood Neighbor Pharmacy — Amerisourcebergen Drug CorporationLuteinizing Hormone ELISA (LH ELISA) (Urine) — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.Easy@Home Ovulation Test Strip (50 tests-bulk pack) — EASY HEALTHCARE CORPORATIONLH-Serum ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungLH AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.CVS Health — WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDOvuQuick Ovulation Predictor Test — VITROLIFE INC.LH — DRG International IncADVIA Centaur® LH — Siemens Healthcare Diagnostics Inc.H.E.B — H. E. BUTT GROCERY COMPANYClearblue — SPD SWISS PRECISION DIAGNOSTICS GMBHEasy@Home Ovulation Test Kit (25 LH strips + 25 HCG strips ) — EASY HEALTHCARE CORPORATIONKroger — KROGER CO., THEEasy@Home Ovulation Test Kit (30 LH strips+30 Cups) — EASY HEALTHCARE CORPORATIONEasy@Home Ovulation Test Kit (50 LH strips + 20 HCG strips ) — EASY HEALTHCARE CORPORATIONWalgreens — WALGREEN CO.AIMSTEP OVULATION — GERMAINE LABORATORIES, INCLH ELISA — DRG Instruments Gesellschaft mit beschränkter Haftungco-innovation — Co-Innovation Biotech Co., LtdDr. Talbot's — TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLCINSTANT Aid By PUR-est — Weihai Kangzhou Biotechnology Engineering Co., LtdLH-Serum ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung
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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