BEUDAMED
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    LKV AGAR, LKV ANAEROBIC AGAR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ANAEROBIC LKV BLOOD AGAR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MITRACLIP G5 DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code NKM·February 6, 2026

    PRAS BBE/LKV Biplate

    FDA UDI
    ANAEROBE SYSTEMS·00810048900107·AS-212 BBE/LKV Bacteroides Bile Esculin (BBE) a...

    PRAS BBE/LKV Biplate

    FDA UDI
    ANAEROBE SYSTEMS·00810048900114·AS-242 BBE/LKV Bacteroides Bile Esculin (BBE) a...

    PRAS BRU PEA LKV Convenience Pack

    FDA UDI
    ANAEROBE SYSTEMS·00810048901302·AS-303 BRU, PEA, and LKV Convenience Pack - Inc...

    PRAS BRU BBE/LKV Convenience Pack

    FDA UDI
    ANAEROBE SYSTEMS·00810048901296·AS-302 BRU and BBE/LKV Convenience Pack - Inclu...

    PRAS BRU PEA BBE/LKV Convenience Pack

    FDA UDI
    ANAEROBE SYSTEMS·00810048901326·AS-323 BRU, PEA, and BBE/LKV Convenience Pack -...

    PRAS BRU PEA BBE LKV Convenience Pack

    FDA UDI
    ANAEROBE SYSTEMS·00810048901333·AS-444 BRU, PEA, BBE, and LKV Convenience Pack ...

    MITRACLIP G5 DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code NKM·June 12, 2025

    PRAS Laked Brucella Blood Agar w/ Kanamycin & Vancomycin (LKV)

    FDA UDI
    ANAEROBE SYSTEMS·00810048900039·AS-142 Laked Brucella Blood Agar with Kanamycin...

    PRAS Laked Brucella Blood Agar w/ Kanamycin & Vancomycin (LKV)

    FDA UDI
    ANAEROBE SYSTEMS·00810048900022·AS-112 Laked Brucella Blood Agar with Kanamycin...

    TLIIQ FETAL FIBRONECTIN TEST

    FDA Adverse Event
    Injury ·HOLOGIC, INC.·Product code LKV·April 6, 2026

    TLIIQ FETAL FIBRONECTIN TEST

    FDA Adverse Event
    Injury ·HOLOGIC, INC.·Product code LKV·April 7, 2025

    TLIIQ FETAL FIBRONECTIN TEST

    FDA Adverse Event
    Injury ·HOLOGIC, INC.·Product code LKV·May 30, 2025

    TLIIQ FETAL FIBRONECTIN TEST

    FDA Adverse Event
    Injury ·HOLOGIC INCORPORATED·Product code LKV·October 19, 2022

    Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 1202 TLiIQ Analyzer Boxed Set (includes Analyzer/Printer and QCette). manufactured by Hologic, Sunnyvale, CA. Medical device for use in assessment of preterm birth risk. Enzyme Immunoassay, Fetal Fibronectin and Device for Specimen Collection (code LIO). The Rapid fFN test is approved for the indication to aid to rapidly assess the risk of preterm delivery in = 7 or = 14 days from the time of cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labor, intact amniotic membranes and minimal cervical dilation (< 3cm), sampled between 24 weeks, 0 days and 34 weeks, 6 days gestation. The test is further indicated for use in conjunction with other clinical information as an aid to rapidly assess the risk of preterm delivery in = 34 weeks, 6 days when a cervicovaginal sample is obtained during a routine prenatal visit between 22 weeks, 0 days and 30 weeks, 6 days of gestation in women with a singleton pregnancy.

    FDA Recall
    Terminated ·Cytyc Prenatal Products/Hologic Inc.·Product code LKV·December 15, 2009

    Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q

    FDA Recall
    Terminated ·Hologic, Inc.·Product code LKV·November 29, 2017

    Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 01166 Rapid fFN Control Kit ; manufactured by Hologic, Sunnyvale, CA. Medical device for use in assessment of preterm birth risk. Enzyme Immunoassay, Fetal Fibronectin and Device for Specimen Collection (code LIO). The Rapid fFN test is approved for the indication to aid to rapidly assess the risk of preterm delivery in = 7 or = 14 days from the time of cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labor, intact amniotic membranes and minimal cervical dilation (< 3cm), sampled between 24 weeks, 0 days and 34 weeks, 6 days gestation. The test is further indicated for use in conjunction with other clinical information as an aid to rapidly assess the risk of preterm delivery in = 34 weeks, 6 days when a cervicovaginal sample is obtained during a routine prenatal visit between 22 weeks, 0 days and 30 weeks, 6 days of gestation in women with a singleton pregnancy.

    FDA Recall
    Terminated ·Cytyc Prenatal Products/Hologic Inc.·Product code lkv·December 15, 2009

    Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200

    FDA Recall
    Terminated ·Hologic, Inc.·Product code LKV·November 29, 2017