Radioimmunoassay, Prolactin (Lactogen)
FDA product code CFT · Class I (low risk) · 21 CFR 862.1625 · Clinical Chemistry
80510(k) clearances
0PMA approvals
6recalls
Manufacturers
- Diagnostic Products Corp. 6
- Abbott Laboratories 5
- Hybritech, Inc. 4
- Bd Becton Dickinson Vacutainer Systems Preanalytic 3
- Medix Biotech, Inc. 3
- Leeco Diagnostics, Inc. 3
- Amersham Corp. 3
- Ciba Corning Diagnostics Corp. 2
- Boehringer Mannheim Corp. 2
- Abbott Mfg., Inc. 2
- Monobind 2
- Bio-Rad Laboratories, Inc. 2
- London Diagnostics, Inc. 2
- Diagnostic Systems Laboratories, Inc. 2
- Serono Diagnostics, Inc. 2
- Microanalytic Research, Inc. 1
- Corning Medical & Scientific 1
- Ventrex Laboratories, Inc. 1
- Cis Radiopharmaceuticals, Inc. 1
- Nuclear Medical Laboratories, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971921 | Prolactin (PRL) Hormone Microplate ElisaCFT · Traditional | Monobind | 06/24/1997SE |
| K970281 | Vitros Immunodiagnostic Products Prolactin Reagent Pack/CalibratorsCFT · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 02/25/1997SE |
| K970188 | Sealite Sciences, Inc. Aqualite ProlactinCFT · Traditional | Sealite Sciences, Inc. | 02/20/1997SE |
| K964748 | Elecsys Prolactin AssayCFT · Traditional | Boehringer Mannheim Corp. | 01/21/1997SE |
| K960561 | DSL Active Prolactin Elisa Model 10-4500CFT · Traditional | Diagnostic Systems Laboratories, Inc. | 04/26/1996SE |
| K960060 | DSL Active Prolactin IrmaCFT · Traditional | Diagnostic Systems Laboratories, Inc. | 02/29/1996SE |
| K954680 | Access Prolactin Assay (Modification)CFT · Traditional | Bio-Rad Laboratories, Inc. | 10/20/1995SE |
| K953656 | Abbott Imx Prolactin(Modification)CFT · Traditional | Abbott Mfg., Inc. | 10/03/1995SE |
| K953657 | Abbott Axsym Prolactin(Modification)CFT · Traditional | Abbott Mfg., Inc. | 09/25/1995SE |
| K944698 | Auraflex Prolactin 200 Test Pack, Calibrator Pack, Dilvent 1CFT · Traditional | Organon Teknika Corp. | 03/21/1995SE |
| K943811 | Enzyme-Linked Fluorescent ImmunoassayCFT · Traditional | Biomerieux Vitek, Inc. | 11/02/1994SE |
| K935675 | Axsym ProlactinCFT · Traditional | Abbott Laboratories | 06/21/1994SE |
| K941220 | Dupont Aca Plus Prolactin (Prol) MethodCFT · Traditional | Dupont Medical Products | 06/03/1994SE |
| K941175 | Access ProlactinCFT · Traditional | Bio-Rad Laboratories, Inc. | 06/02/1994SE |
| K930305 | Cobas Core Prolactin EiaCFT · Traditional | Roche Diagnostic Systems, Inc. | 08/19/1993SE |
| K926386 | Vista Prolactin AssayCFT · Traditional | Syva Co. | 03/29/1993SE |
| K925846 | Immulite ProlactinCFT · Traditional | Diagnostic Products Corp. | 03/05/1993SE |
| K922715 | Immuchem Prl-Mw ElisaCFT · Traditional | Icn Biomedicals, Inc. | 10/05/1992SE |
| K922170 | Amerlite PROLACTIN-30 AssayCFT · Traditional | Eastman Kodak Company | 09/02/1992SE |
| K920921 | Elisa Tube Prolactin Test KitCFT · Traditional | Bio Clinic Co. | 04/08/1992SE |
| K920345 | Prolactin Enzyme Immunoassay Test Kit (Modified)CFT · Traditional | Medix Biotech, Inc. | 03/18/1992SE |
| K914135 | Amerlite(Tm) PROLACTIN-30 Assay, LAN.0086/2086CFT · Traditional | Amersham Corp. | 02/18/1992SE |
| K914107 | Prolactin Irma ImmunomagCFT · Traditional | Pantex, Div. Bio-Analysis, Inc. | 09/30/1991SE |
| K913280 | Opus(R) Prolactin Test SystemCFT · Traditional | Pb Diagnostic Systems, Inc. | 08/16/1991SE |
| K904714 | Ciba Corning Acs Prolactin ImmunoassayCFT · Traditional | Ciba Corning Diagnostics Corp. | 11/07/1990SE |
| K904483 | Elegance Prolactin ElisaCFT · Traditional | Bioclone Australia Pty , Ltd. | 11/05/1990SE |
| K904458 | Lumatag(Tm) Prolactin Diagnostic Kit/ModificationCFT · Traditional | London Diagnostics, Inc. | 10/12/1990SE |
| K902698 | Affinity Prolactin Test SystemCFT · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 07/19/1990SE |
| K901673 | Prolactin (Lactogen) Test SystemCFT · Traditional | Baxter Healthcare Corp | 06/12/1990SE |
| K901578 | Coat-A-Count Prolactin Irma #:IKPR1, IKPR2CFT · Traditional | Diagnostic Products Corp. | 04/19/1990SE |
| K900695 | Enzymun Test(R) ProlactinCFT · Traditional | Boehringer Mannheim Corp. | 03/30/1990SE |
| K896162 | Abbott Imx ProlactinCFT · Traditional | Abbott Laboratories | 01/19/1990SE |
| K896641 | Modified Prolactin Enzyme Immunoassay Test KitCFT · Traditional | Medix Biotech, Inc. | 12/27/1989SE |
| K895380 | SR1 Prolactin (PRL Immunoenzymetric AssayCFT · Traditional | Serono-Baker Diagnostics, Inc. | 10/17/1989SE |
| K894988 | Ciba Corning Magic Lite Prolactin ImmunoassayCFT · Traditional | Ciba Corning Diagnostics Corp. | 10/12/1989SE |
| K895003 | Milenia(Tm) Prolactin (MKPR1,5)CFT · Traditional | Diagnostic Products Corp. | 09/18/1989SE |
| K883878 | Amerlite Prolactin Assay, LAN.0078/2078(240/144)CFT · Traditional | Amersham Corp. | 11/01/1988SE |
| K883747 | Irma-Count(Tm) Prolactin W/Monoclonal AntibodiesCFT · Traditional | Diagnostic Products Corp. | 11/01/1988SE |
| K883269 | Prl-QuantCFT · Traditional | Leeco Diagnostics, Inc. | 09/13/1988SE |
| K881774 | Prolactin Mab Solid Phase Component SystemCFT · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/08/1988SE |
| K880296 | Lumatag(Tm) Prolactin Chemilumines. Immuno. AssayCFT · Traditional | London Diagnostics, Inc. | 03/24/1988SE |
| K880218 | Binax Prolactin Irma Diagnostic KitCFT · Traditional | Binax, Inc. | 03/01/1988SE |
| K874621 | Fiagen(Tm) Prolactin Catalogue Number: 102-201CFT · Traditional | Cyberfluor, Inc. | 01/11/1988SE |
| K873355 | Medix Biotech Prolactin Enzyme Immuno. Test KitCFT · Traditional | Medix Biotech, Inc. | 10/09/1987SE |
| K873400 | Prolactin Maiaclone Immunoradio. Kit, Mag Sol PhaCFT · Traditional | Serono Diagnostics, Inc. | 09/25/1987SE |
| K872862 | PRL Serozyme Immunoenz. Assay Kit, Mag. Solid PhasCFT · Traditional | Serono Diagnostics, Inc. | 09/18/1987SE |
| K871542 | Hprolactin KitCFT · Traditional | Immuchem Corp. | 05/14/1987SE |
| K864439 | Beckman Epsilon(Tm) Prolactin Test KitCFT · Traditional | Beckman Instruments, Inc. | 01/21/1987SE |
| K864075 | Ubi Magiwel(Tm) Prolactin QuantativeCFT · Traditional | United Biotech, Inc. | 12/16/1986SE |
| K863860 | Tandem-M Immunoenzymetric Assay for ProlactinCFT · Traditional | Hybritech, Inc. | 11/21/1986SE |
| K863240 | Prolactin Riabead II Diagnostic KitCFT · Traditional | Abbott Laboratories | 09/29/1986SE |
| K860823 | Elsa-Prol Immunoradiometric Assay KitCFT · Traditional | Cis-Us, Inc. | 08/19/1986SE |
| K861271 | Sucrosep Human Prolactin (HPR) IrmaCFT · Traditional | Boots-Celltech Diagnostics, Inc. | 06/27/1986SE |
| K861542 | Delfia (TM) Human ProlactinCFT · Traditional | Lkb Instruments, Inc. | 06/17/1986SE |
| K861945 | Lee-Bead Prolactin (Eia)CFT · Traditional | Leeco Diagnostics, Inc. | 06/13/1986SE |
| K860221 | Encore Prolactin ReagentCFT · Traditional | Hybritech, Inc. | 03/05/1986SE |
| K854805 | Allegro Prolactin Immunoassay SystemCFT · Traditional | Nichols Institute Diagnostics | 01/28/1986SE |
| K854768 | Terumo Sensibead Eia HPRL KitCFT · Traditional | Terumo Medical Corp. | 01/13/1986SE |
| K851330 | Prolactin System by RiaCFT · Traditional | American Bioclinical, Inc. | 04/29/1985SE |
| K850383 | PRL Quik Ria KitCFT · Traditional | Pacific Biotech, Inc. | 03/01/1985SE |
| K843804 | Tandem - EprlCFT · Traditional | Hybritech, Inc. | 11/13/1984SE |
| K842478 | Prolactin IrmaCFT · Traditional | Euro-Diagnostics BV | 09/14/1984SE |
| K841118 | Prolactin Riabead Prolactin RadioimmCFT · Traditional | Abbott Laboratories | 05/11/1984SE |
| K833925 | Coat-A-Count Nhs-Prolactin Kit andCFT · Traditional | Diagnostic Products Corp. | 01/24/1984SE |
| K831345 | Rianen Prolactin 125I KitCFT · Traditional | New England Nuclear | 06/08/1983SE |
| K830412 | Radioimmunoassay Test System PRLCFT · Traditional | Monobind | 04/05/1983SE |
| K823304 | Riaset Prolactin Ria KitCFT · Traditional | Immulok, Inc. | 12/22/1982SE |
| K822759 | Abbott Laboratories Prolactin EiaCFT · Traditional | Abbott Laboratories | 10/21/1982SE |
| K821545 | Tandem Prolactin KitCFT · Traditional | Hybritech, Inc. | 06/11/1982SE |
| K821305 | Prolactin (125-I) Radioimmunoassay KitCFT · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/24/1982SE |
| K813572 | Centria Prolactin Test SetCFT · Traditional | Ventrex Laboratories, Inc. | 03/26/1982SE |
| K820039 | Leeco Prl-Quant Diagnostic Test KitCFT · Traditional | Leeco Diagnostics, Inc. | 01/22/1982SE |
| K812112 | Marria-Hprl Ria KitCFT · Traditional | Intl. Immunoassay Laboratories, Inc. | 08/13/1981SE |
| K810949 | MRI Prolactin Ria KitCFT · Traditional | Microanalytic Research, Inc. | 07/10/1981SE |
| K803273 | Prolactin (125) RadioimmunaoassayCFT · Traditional | Corning Medical & Scientific | 01/16/1981SE |
| K801849 | Lacti-QuantCFT · Traditional | Nuclear Medical Laboratories, Inc. | 09/16/1980SE |
| K801020 | Gamma Prolactin Radioimmunoassay Kit-CFT · Traditional | Travenol Laboratories, S.A. | 07/08/1980SE |
| K800740 | Prolactin Ria KitCFT · Traditional | Amersham Corp. | 04/16/1980SE |
| K792166 | 125 I Prolactin Hormone Ria KitCFT · Traditional | Diagnostic Products Corp. | 11/13/1979SE |
| K790003 | Ria Kit, ProlactinCFT · Traditional | Cis Radiopharmaceuticals, Inc. | 03/12/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1114-2022 Class II | VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic… | Ortho-Clinical Diagnostics, Inc | 03/25/2022Open, Classified |
| Z-0060-2019 Class II | VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products… | Ortho Clinical Diagnostics Inc | 07/12/2018Open, Classified |
| Z-2087-2018 Class II | ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive HormoneAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | Tosoh Bioscience Inc | 03/05/2018Terminated |
| Z-2610-2017 Class II | Dimension Vista Prolactin (PRL) Flex reagent cartridgeThe concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and… | Siemens Healthcare Diagnostics, Inc. | 03/21/2017Terminated |
| Z-2409-2012 Class III | ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number.…ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for… | Siemens Healthcare Diagnostics, Inc | 08/07/2012Terminated |
| Z-2047-2011 | Active Prolactin ELISA, 96 Wells, DSL-10-4500 The DSL-10-4500 Active Prolactin…The recall was initiated because Beckman Coulter has confirmed that the Active Prolactin ElLISA kit, lot… | Beckman Coulter Inc. | 08/03/2009Terminated |