Whittaker Bioproducts, Inc.
Medical device manufacturer in Walkersville, MD.
30510(k) clearances
0PMA approvals
0recalls
Device types
- LSR Reagent, Borrelia Serological Reagent 4
- LSE Epstein-Barr Virus, Other 4
- LKQ Antibody Igm,If, Cytomegalovirus Virus 2
- LYR Helicobacter Pylori 2
- GNX Antigens, Cf (Including Cf Control)… 2
- GQN Antigen, Cf (Including Cf Control)… 2
- MJH Legionella, Spp., Elisa 1
- LJM Antinuclear Antibody (Enzyme-Labeled)… 1
- DHB System, Test, Radioallergosorbent (Rast)… 1
- LLM Test, Antigen, Nuclear, Epstein-Barr Virus 1
- GNY Antisera, Fluorescent, Adenovirus 1-33 1
- GQG Antigen, Cf (Including Cf Controls)… 1
- LJP Antiserum, Fluorescent, Chlamydia Trachomatis 1
- GQH Antigen, Cf (Including Cf Control)… 1
- LGD Enzyme Linked Immunoabsorbent Assay… 1
- LLL Extractable Antinuclear Antibody, Antigen… 1
- GRB Antiserum, Cf, Mumps Virus 1
- JZT Fluorometer 1
- GRZ Antisera, Fluorescent, All, Mycoplasma Spp. 1
- JTC Device, Microtiter Diluting/Dispensing 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K911356 | Legionella Stat Igg/Igm Test KitMJH · Traditional | 07/30/1992SE |
| K913212 | 3M Ige Single Point Fast TestDHB · Traditional | 11/22/1991SE |
| K904652 | Lyme Stat M Test KitLSR · Traditional | 10/21/1991SE |
| K904893 | Fiax Lyme M Test KitLSR · Traditional | 10/16/1991SE |
| K911473 | Ebna Stat Test KitLLM · Traditional | 09/25/1991SE |
| K905468 | Pylori-G Fiax Test KitLYR · Traditional | 05/07/1991SE |
| K904738 | Pylori Stat Test KitLYR · Traditional | 05/07/1991SE |
| K901493 | Fitc Murine Monoclonal Anti-Influenza Type BGNX · Traditional | 06/27/1990SE |
| K893579 | Fitc Murine Monoclonal Anti-Influenza Type aGNX · Traditional | 01/16/1990SE |
| K894932 | Fiax Eb Vca-M Test KitLSE · Traditional | 10/16/1989SE |
| K894235 | Eb Vca Stat M Test KitLSE · Traditional | 08/30/1989SE |
| K891086 | Stat Test Kit for Eb-Vca Igg AntibodyLSE · Traditional | 05/10/1989SE |
| K885310 | Murine Monoclonal Anti-Adenovirus IggGNY · Traditional | 02/16/1989SE |
| K884516 | Fitc Murine Monoclonal Anti-Rsv IggGQG · Traditional | 01/13/1989SE |
| K883352 | Fluorescein Conjugated Anti-Chlamydia Mono AntiLJP · Traditional | 10/06/1988SE |
| K882024 | Fitc Murine Monoclonal Anti-Cmv IggGQH · Traditional | 08/03/1988SE |
| K882023 | Fiax Test Kit for Eb-Vca-G AntibodyLSE · Traditional | 08/03/1988SE |
| K881180 | Fitc Murine Monoclonal Anti-Herpes Type 1 IggGQN · Traditional | 05/13/1988SE |
| K880996 | Fitc Murine Monoclonal Anti-Hsv Bivalent IggGQN · Traditional | 05/13/1988SE |
| K875113 | Toxostat M Test KitLGD · Traditional | 04/12/1988SE |
| K875286 | Lyme Stat Test KitLSR · Traditional | 03/30/1988SE |
| K873708 | Fiax Test Kit for Ena (Rnp/Sm) AntibodiesLLL · Traditional | 11/25/1987SE |
| K872247 | Fiax Test Kit for Lyme Disease AntibodiesLSR · Traditional | 10/15/1987SE |
| K872733 | Fiax Test Kit for Mumps-G AntibodiesGRB · Traditional | 10/06/1987SE |
| K863798 | Fiax(R) Test Kit Cytomegalovirus M AntibodiesLKQ · Traditional | 04/14/1987SE |
| K863434 | The Fiax 5000 FluorometerJZT · Traditional | 10/29/1986SE |
| K861716 | Fiax Test Kit for Mycoplasma Pneumoniae-G AntibodyGRZ · Traditional | 08/08/1986SE |
| K854839 | Cytomegelisa M Test KitLKQ · Traditional | 02/04/1986SE |
| K844552 | Bio-Stat III Plate WasherJTC · Traditional | 01/30/1985SE |
| K843904 | DNA Stat Test KitLJM · Traditional | 11/01/1984SE |