BEUDAMED
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    QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 3. 0864E7 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 4. Negative Control 0243 Lactobacillus acidophilus derived from ATCC 4356

    FDA Enforcement
    Class II ·Terminated·Microbiologics Inc·March 9, 2022

    QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets include: 1. 0864E3 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 3. 0864E7 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 4. Negative Control 0243 Lactobacillus acidophilus derived from ATCC 4356

    FDA Enforcement
    Class II ·Terminated·Microbiologics Inc·March 9, 2022

    Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.

    FDA Enforcement
    Class II ·Ongoing·Hologic, Inc.·January 22, 2025

    Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.

    FDA Enforcement
    Class II ·Ongoing·Hologic, Inc·April 13, 2022

    Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.

    FDA Enforcement
    Class II ·Terminated·Hardy Diagnostics·May 4, 2016

    Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment prior to vaginal delivery in order to prevent infection of the neonate.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health Inc.·May 27, 2020

    BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada G1P 4S5***BD Max Group B Streptococcus (GBS) Assay is an in vitro diagnostic (IVD) test for detection of GBS DNA in Lim Broth cultures. The BD MAX" PCR Cartridge is a consumable required for the BD MAX" System.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 3, 2013

    NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).

    FDA Enforcement
    Class II ·Terminated·Northeast Laboratory Services, Inc.·April 13, 2016

    NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.: T8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).

    FDA Enforcement
    Class II ·Terminated·Northeast Laboratory Services, Inc.·April 13, 2016

    ARIES GBS Assay , REF 50-10021, UDI # 00840487100165

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S

    FDA Enforcement
    Class II ·Ongoing·EMPATICA SRL·November 1, 2023

    SQ40S Blood Transfusion Filter

    FDA Enforcement
    Class II ·Ongoing·GVS TM, Inc·January 28, 2026

    Intubation Scope Intended to provide optical visualization of, therapeutic access to, and use to facilitate routine or difficult tracheal intubations of the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx and Trachea. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 6, 2016

    On Site Gas Systems POGS 33C Portable Oxygen Generation System

    FDA Enforcement
    Class II ·Terminated·On Site Gas Systems Inc.·January 15, 2014

    MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.

    FDA Enforcement
    Class II ·Terminated·Linde Gas North America Llc·June 26, 2013

    CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200 BM-DK0200 BM-DK0600 BM-DK0800 BM-DK1200 BM-DK1400 BM-DK1800

    FDA Enforcement
    Class II ·Ongoing·GS Biomark LLC·December 7, 2022

    Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VIO PRECUT 122J; Item Number: L15; POLSORB 1 30 VIO PRECUT 224E; Item Number: L405; POLSORB 4/0 60" REEL VIO 217T, Item Number: LL111; POLYSORB 0 18 UNDYED PRECUT, Item Number: L24; POLYSORB 0 18" UNDYED GS-21 DT, Item Number: CL14MG; POLYSORB 0 18" VIOLET PRECUT, Item Number: L27; POLYSORB 0 60 U/D REEL 203G, Item Number: LL104; POLYSORB 1 18" UNDYED PRECUT, Item Number: L25; POLYSORB 1 18" VIOLET GS-21 DT, Item Number: CL11MG; POLYSORB 1 30" VIOLET GS-21 DT, Item Number: CL6M; POLYSORB 1 30" VIOLET GS-22 DT, Item Number: CL885M; POLYSORB 1 30" VIOLET GS-25 DT, Item Number: CL64M; POLYSORB 2 VL 5 X 30" BGST-29 DT, Item Number: CLT633M; POLYSORB 2/0 18" UNDYED GS-10 DT, Item Number: CL52MG; POLYSORB 2/0 18" UNDYED GS-21 DT, Item Number: CL13MG; POLYSORB 2/0 18" VIOLET V-20 DT, Item Number: GL62MG; POLYSORB 2/0 30" VIOLET V-20 DT, Item Number: GL66M; POLYSORB 2-0 30" VIOLET V-30 DT, Item Number: GL223M; POLYSORB 3/0 18" UNDYED V-20 DT, Item Number: GL69MG; POLYSORB 3/0 18" VIOLET CV-25 DT, Item Number: GL33MG and GLJ50M; POLYSORB 3/0 18" VIOLET V-20 DT, Item Number: GL63MG; POLYSORB 3/0 30" VIOLET V-20 DT, Item Number: GL67M; POLYSORB 3/0 60 U/D REEL 104R, Item Number: LL102; POLYSORB 3-0 30" VIOLET CV-25 DT, Item Number: GL182M; POLYSORB 4/0 18" VIOLET CV-25 DT, Item Number: GL34MG; POLYSORB 4/0 30" VIOLET V-20 DT, Item Number: GL68M; POLYSORB* 0 18" VIOLET GS-21 DT, Item Number: CL10MG; POLYSORB* 0 24" VIOLET PRECUT, Item Number: L34; POLYSORB* 0 30" VIOLET GS-21 REG ATTCH, Item Number: 3CL812; POLYSORB* 0 30" VIOLET GS-22 DT, Item Number: CL886M; POLYSORB* 0 30" VIOLET PRECUT, Item Number: L40; POLYSORB* 0 5 X 30" UNDYED GS-21 DT, Item Number: CL2M; POLYSORB* 0 VIOLET 5X30" HGS-20 D-TACH, Item Number: CL997MG; POLYSORB* 0 VIOLET 5X30" HGS-21 D-TACH, Item Number: CL71M; POLYSORB* 0 VIOLET 60 REEL, Item Number: LL114; POLYSORB* 0 VIOLET 98" REEL, Item Number: LL224; POLYSORB* 1 18" VIOLET PRE-CUT, Item Number: L35; POLYSORB* 1 30" VIOLET PRECUT, Item Number: L41; POLYSORB* 1 5 X 30" VIOLET HOS-12 DT, Item Number: CL97MG; POLYSORB* 1 VIOLET 30" GS-26, Item Number: CL60M; POLYSORB* 1 VIOLET 98" REEL, Item Number: LL225; POLYSORB* 2 30" VIOLET GS-25 DT, Item Number: CL665M; POLYSORB* 2 UNDYED 12X18" PRECUT, Item Number: L26; POLYSORB* 2 VIOLET 12X18" PRECUT, Item Number: L28; POLYSORB* 2 VIOLET 2X36" BGS-29 (2X90CM), Item Number: 2CL852; POLYSORB* 2 VIOLET 30" GS-26, Item Number: CL659M; POLYSORB* 2 VIOLET 5X24" GS-24 D-TACH*, Item Number: CL622M; POLYSORB* 2 VIOLET 6X30" PRE-CUT, Item Number: L42; POLYSORB* 2 VIOLET 98" REEL, Item Number: LL226; POLYSORB* 2-0 VIOLET 60 REEL, Item Number: LL113; POLYSORB* 2-0 VIOLET 98" REEL, Item Number: LL223; POLYSORB* 3-0 VIOLET 60 REEL, Item Number: LL112; POLYSORB* 3-0 VIOLET 98" REEL, Item Number: LL222; POLYSORB* 4/0 98" VIOLET REEL 110T, Item Number: LL221

    FDA Enforcement
    Class II ·Terminated·Medtronic·June 21, 2017