Company ยท US
Leica Biosystems Richmond Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2014. Name variants (Inc, Corp, punctuation) are merged.
1510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 14, 2017 | Leica Biosystems Richmond Inc. Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intended for in vitro diagnostic (IVD) use. SOX-10 Rabbit Polyclonal Primary Antibody is intended for laboratory use in the de Terminated |
NJT | None listed |
| Jul 14, 2017 | Leica Biosystems Richmond Inc. Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in Terminated |
NJT | None listed |
| Jul 14, 2017 | Leica Biosystems Richmond Inc. Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD,
The antibody is intended for in vitro diagnostic (IVD) use. Napsin A (MRQ-60) Mouse Monoclonal Primary Antibody is intended for laboratory Terminated |
NJT | None listed |
| Jul 14, 2017 | Leica Biosystems Richmond Inc. Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD,
The antibody is intended for in vitro diagnostic (IVD) use. MSH6 is a mismatch repair gene which is deficient in a high proportion of patients wit Terminated |
NJT | None listed |
| Jul 14, 2017 | Leica Biosystems Richmond Inc. Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD,
The antibody is intended for in vitro diagnostic (IVD) use. The Microphthalmia Transcription Factor (MiTF Terminated |
NJT | None listed |
| Jul 14, 2017 | Leica Biosystems Richmond Inc. Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Glypican-3 (1G12) Mouse Monoclonal Primary Antibody is intended for laboratory us Terminated |
NJT | None listed |
| Jul 14, 2017 | Leica Biosystems Richmond Inc. Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD,
The antibody is intended for in vitro diagnostic (IVD) use. The Podoplanin (D2-40) antibody is intended for qualified laboratories to qua Terminated |
NJT | None listed |
| May 6, 2016 | Leica Biosystems Richmond Inc. Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of Terminated |
NQN | K031715 K033200 +1 |
| May 2, 2016 | Leica Biosystems Richmond Inc. CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assis Terminated |
JOY | K042542 |
| Mar 29, 2012 | Leica Biosystems Richmond Inc. Surgipath Cyto Jar Fixative; a 120 mL clear, leakproof container prefilled with 45 mL of preservative containing polyethylene glycol for the convenient collection, fixation and preservation of all cyt Terminated |
LEA | None listed |