General Purpose Reagent
Regulation 864.4010
0510(k)s in 12 months (16 all time)
4recalls in 12 months (30 all time)
0recalls that name a 510(k)
Top companies in PPM
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2026 | Immuno-Mycologics, Inc Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60
For processing of clinical specimens for Mycobacterium spp. diagnosis Open, Classified |
PPM | None listed |
| Dec 18, 2025 | Copan Italia 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk Open, Classified |
PPM | None listed |
| Dec 18, 2025 | Copan Italia 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP*
*Compatible with Copan s WASP (Walk-Away Specimen Processor for Microbiology) System Open, Classified |
PPM | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Akkermansia Test Open, Classified |
PPM | None listed |
| Jun 18, 2025 | Diagnostica Stago, Inc. STA - Owren Koller. Model/Catalog Number: 00360
STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of t Open, Classified |
PPM | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3. Open, Classified |
PPM | None listed |
| Nov 6, 2024 | Biocare Medical, LLC intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB
Buffer, Catalog Number: IPBF5009G20;
ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPR Open, Classified |
PPM | None listed |
| Jul 3, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754.
Product Description: VITROS Chemistry Products FS Diluent Pack 3 comes with 3 packs per sales unit. Open, Classified |
PPM | None listed |
| Mar 25, 2024 | Beckman Coulter, Inc. Access Substrate, REF 81906, For use with the Access Immunoassay Systems Open, Classified |
PPM | None listed |
| Jul 28, 2023 | NeuMoDx Molecular Inc NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems (NeuMoDx System(s)
Ref: 100100 Open, Classified |
PPM | None listed |
| Jul 20, 2022 | bioMerieux, Inc. NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit. Open, Classified |
PPM | None listed |
| May 20, 2022 | Agilent Technologies, Inc. Kit Label:
Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2
Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21
Vial Labels:
Mat. No K589911-21512 Open, Classified |
PPM | None listed |
| Feb 14, 2022 | Cytocell Ltd. Cytocell 8 Square Template Slides (Glass)- microscope slides
Reference: PCN008 Terminated |
PPM | None listed |
| Nov 22, 2021 | Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack Open, Classified |
PPM | None listed |
| Jun 24, 2020 | DNA Genotek Inc. PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected usin Terminated |
PPM | None listed |
| Feb 11, 2020 | BIOMERIEUX - Grenoble NUCLISENS Lysis Buffer, IVD, REF 200292, 48X2 ML LYS
Manufacturer
bioMerieux SA
376, Chemin de l'Orme
69280 Marcy-l'Etoile - France - Product Usage: to be used for the release of total nucleic acid fr Terminated |
PPM | None listed |
| Oct 8, 2018 | bioMerieux, Inc. bioMrieux NucliSENS easyMAG Lysis Buffer ref. 280134 Terminated |
PPM | None listed |
| Sep 17, 2018 | BioMerieux SA NucliSENS Magnetic Extraction Reagents Terminated |
PPM | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
PPM | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
PPM | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
PPM | None listed |
| Mar 2, 2018 | Becton Dickinson & Co. BD MAX DNA MMK Lab Use, catalog no. 442828 Terminated |
PPM | None listed |
| Mar 2, 2018 | Becton Dickinson & Co. BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829 Terminated |
PPM | None listed |
| Feb 27, 2018 | Ventana Medical Systems Inc ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic Terminated |
PPM | None listed |
| Feb 27, 2018 | Ventana Medical Systems Inc ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 in vitro diagnostic Terminated |
PPM | None listed |
| Feb 27, 2018 | Ventana Medical Systems Inc ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro diagnostic Terminated |
PPM | None listed |
| Oct 18, 2017 | BioMerieux SA NucliSENS Lysis Buffer
Extended lot for RES 76675 Terminated |
PPM | None listed |
| Mar 19, 2017 | BioMerieux SA NucliSENS Lysis Buffer, REF 200292
NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid from biological specimens Terminated |
PPM | None listed |
| Jan 13, 2017 | BioMerieux SA NucliSENS magnetic extraction reagents, For in vitro diagnostic use,
Product Usage:
NucliSENS miniMAG is intended to be used for the extraction of total nucleic acids from biological specimens. Terminated |
PPM | None listed |
| Jan 13, 2017 | BioMerieux SA MagSIL (NucliSENS easyMAG Magnetic Silica),
Product Usage:
The NucliSENS easyMAG system is an in vitro diagnostic medical device and is intended for the automated isolation (purification and concent Terminated |
PPM | None listed |
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