14 results
·
13ms
·
Sources: EU EUDAMED, US FDA
Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. THE MASCT SYSTEM KIT CONSISTS OF: 1. MASCT Breast Pump; 2. Instructions for Use (IFU); 3. Heating Pad; 4. Timer; 5. Saccomono's Fixative; 6. Nu Prep Gel; 7. Welcome and Training Materials Coversheet; 8. MASCT System Order Form; 9. ForeCYTE Training Video DVD; 10. MASCT System Instructions with pictures - pink; THE PATIENT SAMPLE KIT CONSISTS OF: 1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder); 2. Instructions for Use (IFU); 3. Two (2) specimen collection devices; 4. Two (2) breast bags for transporting the specimen collection container; 5. Barcode labels; 6. Saccomono's Fixative; 7. Nu Prep Gel; 8. MASCT System package insert; 9. ForeCYTE Test Requisition Form; 10. Patient Information Sheet; 11. Atossa Patient Information; 12. FED EX Clinical PAK; 13. MASCT System Order Form; 14. FED EX Pouch; 15. FED EX Airbill; Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.
FDA Enforcement
Class I
·Terminated·Atossa Genetics, Inc.·November 6, 2013
Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.
FDA Enforcement
Class II
·Terminated·On-X Life Technologies, Inc.·February 1, 2017
3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes.
FDA Enforcement
Class II
·Terminated·Greiner Bio-One North America, Inc.·August 15, 2012
VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or whole blood in the clinical laboratory.
FDA Enforcement
Class II
·Terminated·Greiner Bio-One North America, Inc.·January 29, 2020
VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.
FDA Enforcement
Class II
·Terminated·Greiner Bio-One North America, Inc.·April 22, 2020
Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged
FDA Enforcement
Class II
·Terminated·Greiner Bio-One North America, Inc.·September 29, 2021
Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine venipuncture procedures. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with instructions for use.
FDA Enforcement
Class II
·Terminated·Greiner Bio-One North America, Inc.·July 11, 2012
4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluoride, and an anticoagulant, potassium oxalate. The product is suitable for the analysis of blood glucose and lactate
FDA Enforcement
Class II
·Terminated·Greiner Bio-One North America, Inc.·June 15, 2016
VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.
FDA Enforcement
Class II
·Terminated·Greiner Bio-One North America, Inc.·February 27, 2013
VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: are used to collect, transport, and process blood for testing serum, plasma or whole blood in the clinical laboratory.
FDA Enforcement
Class II
·Terminated·Greiner Bio-One North America, Inc.·October 7, 2020
VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: indicated for use in collection and transport of venous whole blood for coagulation testing.
FDA Enforcement
Class II
·Terminated·Greiner Bio-One North America, Inc.·May 12, 2021
VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
FDA Enforcement
Class II
·Terminated·Greiner Bio-One North America, Inc.·October 6, 2021
greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P
FDA Enforcement
Class II
·Terminated·Greiner Bio-One North America, Inc.·January 26, 2022
On Site Gas Systems POGS 33C Portable Oxygen Generation System
FDA Enforcement
Class II
·Terminated·On Site Gas Systems Inc.·January 15, 2014