ClearanceBrief
Panels › Pathology › Product code PPM · Class 1

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)
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Top companies in PPM

DateFirm and productCodeLinked 510(k)
Apr 29, 2026Immuno-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
PPMNone listed
Dec 18, 2025Copan Italia
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
Open, Classified
PPMNone listed
Dec 18, 2025Copan 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
PPMNone listed
Dec 1, 2025GET TESTED INTERNATIONAL AB
Akkermansia Test
Open, Classified
PPMNone listed
Jun 18, 2025Diagnostica 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
PPMNone listed
May 27, 2025Mckesson Medical-Surgical Inc. Corporate Office
ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3.
Open, Classified
PPMNone listed
Nov 6, 2024Biocare 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
PPMNone listed
Jul 3, 2024Ortho-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
PPMNone listed
Mar 25, 2024Beckman Coulter, Inc.
Access Substrate, REF 81906, For use with the Access Immunoassay Systems
Open, Classified
PPMNone listed
Jul 28, 2023NeuMoDx 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
PPMNone listed
Jul 20, 2022bioMerieux, Inc.
NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
Open, Classified
PPMNone listed
May 20, 2022Agilent 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
PPMNone listed
Feb 14, 2022Cytocell Ltd.
Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008
Terminated
PPMNone listed
Nov 22, 2021Ortho-Clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Open, Classified
PPMNone listed
Jun 24, 2020DNA 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
PPMNone listed
Feb 11, 2020BIOMERIEUX - 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
PPMNone listed
Oct 8, 2018bioMerieux, Inc.
bioMrieux NucliSENS easyMAG Lysis Buffer ref. 280134
Terminated
PPMNone listed
Sep 17, 2018BioMerieux SA
NucliSENS Magnetic Extraction Reagents
Terminated
PPMNone listed
Sep 14, 2018Ventana Medical Systems Inc
ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098 Immunohistochemistry (IHC) for in vitro diagnostic use.
Terminated
PPMNone listed
Sep 14, 2018Ventana Medical Systems Inc
VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.
Terminated
PPMNone listed
Sep 14, 2018Ventana Medical Systems Inc
ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 Immunohistochemistry (IHC) for in vitro diagnostic use.
Terminated
PPMNone listed
Mar 2, 2018Becton Dickinson & Co.
BD MAX DNA MMK Lab Use, catalog no. 442828
Terminated
PPMNone listed
Mar 2, 2018Becton Dickinson & Co.
BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829
Terminated
PPMNone listed
Feb 27, 2018Ventana Medical Systems Inc
ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic
Terminated
PPMNone listed
Feb 27, 2018Ventana Medical Systems Inc
ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 in vitro diagnostic
Terminated
PPMNone listed
Feb 27, 2018Ventana Medical Systems Inc
ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro diagnostic
Terminated
PPMNone listed
Oct 18, 2017BioMerieux SA
NucliSENS Lysis Buffer Extended lot for RES 76675
Terminated
PPMNone listed
Mar 19, 2017BioMerieux 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
PPMNone listed
Jan 13, 2017BioMerieux 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
PPMNone listed
Jan 13, 2017BioMerieux 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
PPMNone listed

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