Home › Device types › JLX
Radioimmunoassay, 17-Hydroxyprogesterone
FDA product code JLX · Class 1 · Clinical Chemistry
42
Registered devices
7
Adverse events
3
Recalls
19
510(k) clearances
Devices with this code
N-17-OHP AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.17-alpha Hydroxy Progesterone ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.17OHP AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.17 OH-Progesterone ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungAutoDELFIA Neonatal 17α-OH-progesterone kit — Wallac OyProgesterone, 17 a-Hydroxy- (Neonate) (MW) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung17 OH Progesterone ELISA — DRG International Inc17-OH-Progesterone ELISA — IBL International GmbHAutoDELFIA Neonatal 17α-OH-progesterone kit — Wallac OyN-17-OHP AccuBind ELISA Test System - 1920 Wells — MONOBIND, INC.Progesterone (17-a-OH Progesterone) — DRG Instruments Gesellschaft mit beschränkter HaftungProgesterone, 17 a-Hydroxy- (Neonate) (MW) ELISA — DRG International IncN-17-OHP AccuBind ELISA Test System - 960 Wells — MONOBIND, INC.N-17-OHP AccuBind ELISA Test System - 480 Wells — MONOBIND, INC.17OHP AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.Monobind AccuLite 17OHP-SI CLIA Kit - 192 Wells — MONOBIND, INC.DBC 17α-Hydroxyprogesterone (17α-OHP) ELISA — Diagnostics Biochem Canada IncAccuDiag™ 17-alpha-OH Progesterone ELISA — Diagnostic Automation, Inc.17OHP AccuLite CLIA Test System - 192 Wells — MONOBIND, INC.Salivary 17-OH Progesterone ELISA — DRG International IncSalivary 17-OH Progesterone ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung17OHP-SI AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.Salivary 17-OH Progesterone ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungC-Peptide ELISA — DRG International Inc
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-13 | DRG International, Inc. | The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range information on the High and Low Control Comp |
| 2023-04-05 | Siemens Healthcare Diagnostics, Inc. | Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a |
| 2023-04-05 | Siemens Healthcare Diagnostics, Inc. | Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a |
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