Bio-Techne
Diagnostics makerAI. FDA files no records under this name; these are its 3 companies' records, each linked to the record.
- Records across the group: 87, 4 entitiesAI
- 510(k) clearances: 81
- Device recalls: 6
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Bio-Techne and its 3 subsidiaries
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Nov 7, 2022 | R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N; (2) CBC-3D TRI PClass III · For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial conta | Device recalls |
| Jun 14, 2022 | Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations iClass III · The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm contains an error associa | Device recalls |
| Jan 20, 2021 | Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked immunosorbent assayClass II · R&D Systems, Inc. received two complaints that the standard signal was low and controls were not within the specificatio | Device recalls |
| Feb 21, 2020 | AmplideX Fragile X Dx & Carrier Screen KitDEN190023 · OYV | 510(k) clearances |
| Nov 1, 2018 | Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked immunosorbent assay is inteClass III · The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card nu | Device recalls |
| Sep 11, 2018 | R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971Class III · The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D1/4 label incorrectly s | Device recalls |
| Jan 19, 2017 | meso-relle (AAL34, AAL36, AM30G)K161255 · FMI | 510(k) clearances |
| Sep 1, 2016 | BC-5D Hematology ControlK160606 · JPK | 510(k) clearances |
| Aug 24, 2016 | R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations Class II · R&D Systems, Inc. received two customer complaints that results of the Controls provided with the Quantikine¿ IVD¿ Human | Device recalls |
| Jul 22, 2016 | Quantidex qPCR BCR-ABL IS KitDEN160003 · OYX | 510(k) clearances |
| Jul 24, 2013 | R&D 5D RETIC HEMATOLOGY CONTROLK130962 · JPK | 510(k) clearances |
| Mar 16, 2012 | RNARETAINK113420 · OZF | 510(k) clearances |
| Apr 28, 2011 | R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROLK101578 · JPK | 510(k) clearances |
| Jan 29, 2010 | R & D SYSTEMS XERET HEMATOLOGY CONTROLK100050 · JPK | 510(k) clearances |
Subsidiaries and Divisions
3 firms in the Bio-Techne group, most records first- R&D Systems85 records
- Asuragen, Inc.1 record
- Biotekne Srl1 record
Canada and Imports
Across the Bio-Techne group, matched by company nameNames and Identifiers
- Appears as
- Website
- bio-techne.com
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built