Ventrex Laboratories, Inc.
Medical device manufacturer in Portland, ME.
82510(k) clearances
0PMA approvals
0recalls
Device types
- DHB System, Test, Radioallergosorbent (Rast)… 18
- DGC Ige, Antigen, Antiserum, Control 12
- JHI Visual, Pregnancy Hcg, Prescription Use 4
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 4
- KHQ Radioassay, Triiodothyronine Uptake 2
- KIT Media And Components, Synthetic Cell And… 2
- GTZ Antisera, All Groups, Streptococcus Spp. 2
- JIT Calibrator, Secondary 2
- CGR Radioimmunoassay, Cortisol 2
- CFP Radioimmunoassay, Immunoreactive Insulin 2
- KQN Radioassay, Angiotensin Converting Enzyme 2
- CDP Radioimmunoassay, Total Triiodothyronine 2
- CDX Radioimmunoassay, Total Thyroxine 2
- CDD Radioassay, Vitamin B12 1
- DBF Ferritin, Antigen, Antiserum, Control 1
- CEW Radioimmunoassay, Parathyroid Hormone 1
- JPK Mixture, Hematology Quality Control 1
- CEC Radioimmunoassay, Free Thyroxine 1
- DHX System, Test, Carcinoembryonic Antigen 1
- DPO Radioimmunoassay, Digoxin (125-I), Rabbit… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K914554 | Specific Ige Eia-Turbo AssayDHB · Traditional | 03/13/1992SE |
| K913833 | Ventrex Allergen DiscDHB · Traditional | 02/21/1992SE |
| K913434 | Ventrex Coated Tube Intact PTHCEW · Traditional | 10/25/1991SE |
| K905612 | Ventrex Coated Tube Ige RadioimmunoassayDGC · Traditional | 02/21/1991SE |
| K905636 | Ventrex Coated Tube Ige Enzyme ImmunoassayDHB · Traditional | 02/07/1991SE |
| K905247 | SHBG Irma KitCDZ · Traditional | 01/17/1991SE |
| K904330 | Turbo-Rast Specific Ige AssayDHB · Traditional | 12/07/1990SE |
| K903000 | Turbo-Rast Specific Ige AssayJHR · Traditional | 07/31/1990SE |
| K897083 | Ventresign Strep a TestGTZ · Traditional | 01/22/1990SE |
| K895649 | Coated Tube High Sensitivity TSH 200 Uiu/Ml Stan.JIT · Traditional | 01/18/1990SE |
| K895648 | Coated Tube High Sensitivity TSH 100 Uiu/Ml Stan.JIT · Traditional | 01/18/1990SE |
| K896852 | Ventrex Coated Tube Ige Enzyme ImmunoassayDHB · Traditional | 12/18/1989SE |
| K896694 | Ventrezyme Vast Specific Ige AssayDHB · Traditional | 12/08/1989SE |
| K891068 | Ventrex Coated Tube T3 UptakeKHQ · Traditional | 04/10/1989SE |
| K890549 | Ventrex Coated Tube HCGJHI · Traditional | 03/28/1989SE |
| K885157 | Ventrex Coated Tube High Sensitivity TSHJLW · Traditional | 02/10/1989SE |
| K883342 | Ventrex Coated Tube TSHJLW · Traditional | 09/13/1988SE |
| K880678 | Modified Ventrescreen Beta HCG Enzyme ImmunoassayDHA · Traditional | 04/05/1988SE |
| K880547 | Ventrezyme Vast Immuno-Peroxidase AssayDHB · Traditional | 03/25/1988SE |
| K874258 | Ventrescreen, HCG UrineJHI · Traditional | 11/23/1987SE |
| K873647 | Ventrescreen Capillary Blood Collection TubeGIO · Traditional | 10/20/1987SE |
| K872032 | Ventrescreen (TM) MonoKTN · Traditional | 06/29/1987SE |
| K871331 | Ventrescreen Cat/Dog Allergy Test Kit Enzyme Immu.DHB · Traditional | 04/28/1987SE |
| K870009 | Ventrescreen Mite/Mold Allergy Test Kit Enzyme Im.DHB · Traditional | 04/14/1987SE |
| K870876 | HL-1 SupplementKIT · Traditional | 03/31/1987SE |
| K870624 | Ventrex Ip Specific E Enzyme ImmunoassayDHB · Traditional | 03/24/1987SE |
| K862901 | Ventrescreen II Pollens Enzyme ImmunoassayDHB · Traditional | 09/16/1986SE |
| K861919 | Ventrex Apo BMSJ · Traditional | 06/06/1986SE |
| K850895 | Ventrezyme, Vast Immunoperoxidase AssayDHB · Traditional | 10/16/1985SE |
| K851403 | Ventrezyme Allergen Data Reduction SystemJQW · Traditional | 06/21/1985SE |
| K844855 | Ventrescreen Strep a TestGTZ · Traditional | 01/16/1985SE |
| K843230 | Ventrezyme Pap Kit Immunoassay ProstaticJFH · Traditional | 09/04/1984SE |
| K842264 | Ventrezyme Phenobarbital Kit ImmunoDLZ · Traditional | 08/14/1984SE |
| K842161 | Ventrezyme Phenytoin Kit ImmunoassayDIP · Traditional | 07/09/1984SE |
| K842239 | Ventrescreen Strep a TestGWC · Traditional | 07/02/1984SE |
| K841993 | HL-1, Defined Serum Free MediaKIT · Traditional | 06/25/1984SE |
| K841651 | Vast Ventrex Rast AllDGC · Traditional | 06/01/1984SE |
| K840830 | Ventria Apo A-1 ALPHA-1 LipotroteinDER · Traditional | 05/21/1984SE |
| K841516 | Ventrescreen, Multiple Allergen DiscsDHB · Traditional | 05/11/1984SE |
| K841024 | Ventrezyme T4U Immunoassay T4UCEE · Traditional | 05/09/1984SE |
| K841081 | Ventrezyme Beta-Hcg Immunoassay HCGJHI · Traditional | 05/07/1984SE |
| K841023 | Coated Tube HCG Immunoassay HCGJHI · Traditional | 05/01/1984SE |
| K833423 | Ventrezyme Eia Controls-ImmunoassayJJY · Traditional | 12/08/1983SE |
| K832218 | Allergen Control InhalentDGC · Traditional | 09/20/1983SE |
| K832217 | Ventre/Spec Allergen Control-Molds/FoodDHB · Traditional | 09/20/1983SE |
| K831554 | Nein Allergen Disc in Vast Ventrex TestDHB · Traditional | 06/08/1983SE |
| K831485 | Ventre/Zyme Ige KitDGC · Traditional | 06/02/1983SE |
| K830928 | Ventrex Enzyme TSH KitJLW · Traditional | 04/28/1983SE |
| K831091 | New Allergen Disc -Vast Ventex AllergyDHB · Traditional | 04/27/1983SE |
| K830817 | New Allergen Discs for Use in Vast VentDGC · Traditional | 04/27/1983SE |
| K830170 | Riassist Rast Data Reduction/QualityDHB · Traditional | 02/07/1983SE |
| K822860 | Ria Ssist TI-59 Magnetic Card ProgramsJQP · Traditional | 10/27/1982SE |
| K822442 | Vast Ventrex Rast Allergen DiscsDGC · Traditional | 09/02/1982SE |
| K821451 | Vast Ventrex Allergy Systems TestsDHB · Traditional | 06/23/1982SE |
| K820978 | Ventre/Spec Allergen Control-InhalantDGC · Traditional | 06/11/1982SE |
| K820977 | Ventre/Spec Allergen Control-Molds/FoodDGC · Traditional | 06/11/1982SE |
| K821615 | Vast Ventrex PD Ige Ria Test SetDGC · Traditional | 06/10/1982SE |
| K820897 | Ventre/Spec Ige ControlsDGC · Traditional | 05/05/1982SE |
| K821011 | Ace Activity Microvial Test SetKQN · Traditional | 05/03/1982SE |
| K820896 | Ventrex 125I Anti-Ige Allergy IsotopeDGC · Traditional | 04/21/1982SE |
| K820298 | Carcinoembryonic Antigen Control (4 LevDHX · Traditional | 04/08/1982SE |
| K813572 | Centria Prolactin Test SetCFT · Traditional | 03/26/1982SE |
| K813465 | Free T4 Ria Test SetCEC · Traditional | 12/31/1981SE |
| K812357 | Ventrex Data Reduction & Qual. Contr. SyJPK · Traditional | 09/01/1981SE |
| K811559 | Ventre/Sep Ige Ria Test SetDGC · Traditional | 07/10/1981SE |
| K811423 | Ventre/SepCFP · Traditional | 06/09/1981SE |
| K801560 | Ventrex/Sep TSH Test SetJLW · Traditional | 08/13/1980SE |
| K800594 | Ventre/Sep Cortisol RiaCGR · Traditional | 04/04/1980SE |
| K800165 | Ventre/Sep T3 Uptake RadioassayKHQ · Traditional | 02/13/1980SE |
| K792243 | Centria Cortisol Ria Test SetCGR · Traditional | 12/06/1979SE |
| K791216 | Centria Vitamin B12 Folate Radio SetCDD · Traditional | 11/13/1979SE |
| K791896 | Centria Phenytoin Ria Test SetDLP · Traditional | 10/17/1979SE |
| K791707 | Centria Insulin RiaCFP · Traditional | 10/17/1979SE |
| K791588 | Ventre/Sep T3 Test SetCDP · Traditional | 09/27/1979SE |
| K791712 | Angiotensin Converting Enzyme Assay SysKQN · Traditional | 09/19/1979SE |
| K791368 | Ventre/Sep T4 Test SetCDX · Traditional | 09/17/1979SE |
| K791355 | Ventre/Sep Digoxin Radioimmunoassay KitDPO · Traditional | 08/10/1979SE |
| K790908 | Ria, Test Set Centria T3CDP · Traditional | 06/27/1979SE |
| K791050 | Centria T3 Uptake Test Set · Traditional | 06/15/1979SE |
| K790800 | Centria T4 Ria Test SetCDX · Traditional | 06/15/1979SE |
| K790540 | Ria Test Kit, Centria DigoxinDPB · Traditional | 04/23/1979SE |
| K790447 | Ventre/Sep Ferritin RiaDBF · Traditional | 04/23/1979SE |