Liofilchem S R L

FDA Filings

This page includes the latest FDA filings for Liofilchem S R L. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3012389632
FEI Number3012389632
NameLIOFILCHEM S.R.L.
Owner & OperatorLiofilchem S.R.L.
Contact AddressVia Scozia, Zona Industriale
Roseto degli Abruzzi IT-TE Teramo 64026 IT
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressVia Scozia, Zona Industriale
Roseto degli Abruzzi Teramo, 64026 IT
Establishment TypeManufacture Medical Device



Registration Number3013661582
FEI Number3013661582
NameLiofilchem, Inc.
Owner & OperatorLiofilchem S.R.L.
Contact AddressVia Scozia, Zona Industriale
Roseto degli Abruzzi IT-TE Teramo 64026 IT
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address465 Waverley Oaks Rd. Suite 317
Waltham, MA 02452 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



Registration Number3003059313
FEI Number3003059313
NameLaboratory Specialists, Inc.
Owner & OperatorLiofilchem S.R.L.
Contact AddressVia Scozia, Zona Industriale
Roseto degli Abruzzi IT-TE Teramo 64026 IT
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address26214 Center Ridge Road
Cleveland, OH 44145 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) $92140-12025-03-27
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9214002025-03-27
LIOFILCHEM SRL
ComASP 75009U2023-06-08
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9215602022-02-07
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9213902022-02-07
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9213502022-02-07
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9211402022-02-07
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9210402022-02-07
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9210302022-02-07
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9208102022-02-07
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9207602022-02-07
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9207102022-02-07
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9207002022-02-07
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9206802022-02-07
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9206402022-02-07
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9204502022-02-07
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9203002022-02-07
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9202702022-02-07
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9200902022-02-07
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9207402022-02-07
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9205102022-02-07
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9208002022-02-07
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9205302022-02-07
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9213802022-02-07
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9213602022-02-07
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9207202022-02-07
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9208402022-02-04
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9205702022-02-04
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9205702022-02-04
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) 9213702022-02-04
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) $92108-12021-11-04
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) $92108-102021-11-04
Liofilchem S. R. L.
MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL2021-10-20
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) $92064-102020-05-25
LIOFILCHEM SRL
Liofilchem MTS (MIC Test Strip) $92064-12020-05-25
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS Lefamulin 0.016-256 ug/mL2020-04-07
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS Lefamulin 0.016-256 ug/mL2020-04-07
LIOFILCHEM S.R.L.
MTS Lefamulin 0.016-256 ug/mL2020-04-07
LIOFILCHEM SRL
Liofilchem Mic Test Strip (MTS) $92071-102020-04-01
LIOFILCHEM SRL
Liofilchem Mic Test Strip (MTS) $92071-12020-04-01
Liofilchem S. R. L.
MTS Omadacycline 0.002 - 32 Ug/mL2020-03-20
LIOFILCHEM SRL
Liofilchem Mic Test Strip (MTS) $92027-12019-12-16
LIOFILCHEM SRL
Liofilchem Mic Test Strip (MTS) $92027-102019-12-16
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS Ampicillin-sulbactam 0.016/0.008-256/128 ug/mL2019-11-01
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS Ampicillin-sulbactam 0.016/0.008-256/128 ug/mL2019-11-01
LIOFILCHEM S.R.L.
MTS Ampicillin-sulbactam 0.016/0.008-256/128 ug/mL2019-11-01
Liofilchem S. R. L.
MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL2019-10-31
LIOFILCHEM SRL
Liofilchem MIC Test Strip (MTS) $92068-12019-09-24
LIOFILCHEM SRL
Liofilchem Mic Test Strip (MTS) $92068-102019-09-24
LIOFILCHEM SRL
Liofilchem MIC Test Strip $92156-012019-09-20
LIOFILCHEM SRL
Liofilchem MIC Test Strip $92156-102019-09-20
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS Imipenem 0.016 - 256 ug/mL2019-09-06
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS Imipenem 0.016 - 256 ug/mL2019-09-06
LIOFILCHEM S.R.L.
MTS Imipenem 0.016 - 256 ug/mL2019-09-06
Liofilchem S.r.l.
MTS Imipenem 0.016-256 µg/mL2019-09-04
Liofilchem S. R. L.
MTS Imipenem-relebactam 0.002/4-32/4 µg/mL2019-08-23
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS Imipenem-relebactam 0.002/4 - 32/4 ug/mL2019-08-23
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS Imipenem-relebactam 0.002/4 - 32/4 ug/mL2019-08-23
LIOFILCHEM S.R.L.
MTS Imipenem-relebactam 0.002/4 - 32/4 ug/mL2019-08-23
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS Doxycycline 0.016-256 ug/mL2019-05-30
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS Doxycycline 0.016-256 ug/mL2019-05-30
LIOFILCHEM S.R.L.
MTS Doxycycline 0.016-256 ug/mL2019-05-30
Liofilchem S. R. L.
MTS Doxycycline 0.016 - 256 µg/mL2019-05-29
LIOFILCHEM SRL
Liofilchem Mic Test Strip (MTS) $92081-12019-04-29
LIOFILCHEM SRL
Liofilchem Mic Test Strip (MTS) $92045-12019-04-29
LIOFILCHEM SRL
Liofilchem Mic Test Strip (MTS) $92081-102019-04-29
LIOFILCHEM SRL
Liofilchem Mic Test Strip (MTS) $92045-102019-04-29
Liofilchem S. R. L.
MTS Gentamicin 0.016 - 256 µg/mL2019-03-22
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS Gentamicin 0.016 - 256 ug/mL2019-03-22
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS Gentamicin 0.016 - 256 ug/mL2019-03-22
LIOFILCHEM S.R.L.
MTS Gentamicin 0.016 - 256 ug/mL2019-03-22
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS Ciprofloxacin 0.002 - 32 ug/mL2019-03-20
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS Ciprofloxacin 0.002 - 32 ug/mL2019-03-20
LIOFILCHEM S.R.L.
MTS Ciprofloxacin 0.002 - 32 ug/mL2019-03-20
Liofilchem S. R. L.
MTS Ciprofloxacin 0.002 - 32 µg/mL2019-03-19
Liofilchem S.r.l.
MTS Tetracycline 0.016 - 256 Ug/mL2019-01-11
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS Tetracycline 0.016 - 256 ug/mL2019-01-11
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS Tetracycline 0.016 - 256 ug/mL2019-01-11
LIOFILCHEM S.R.L.
MTS Tetracycline 0.016 - 256 ug/mL2019-01-11
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS?Levofloxacin 0.002-32 ug/mL2018-12-21
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS?Levofloxacin 0.002-32 ug/mL2018-12-21
LIOFILCHEM S.R.L.
MTS?Levofloxacin 0.002-32 ug/mL2018-12-21
Liofilchem S. R. L.
MTS Levofloxacin 0.002 - 32 µg/mL2018-12-20
Liofilchem S. R. L.
MTS Omadacycline 0.002-32 µg/mL2018-12-14
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Omadacycline 0.002-32 ?g/mL2018-12-14
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Omadacycline 0.002-32 ?g/mL2018-12-14
LIOFILCHEM S.R.L.
MTS? (MIC Test Strip) Omadacycline 0.002-32 ?g/mL2018-12-14
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Eravacycline 0.002-32 ?g/mL2018-11-02
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Eravacycline 0.002-32 ?g/mL2018-11-02
LIOFILCHEM S.R.L.
MTS? (MIC Test Strip) Eravacycline 0.002-32 ?g/mL2018-11-02
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Penicillin G 0.002-32 ?g/mL2018-09-14
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Penicillin G 0.002-32 ?g/mL2018-09-14
LIOFILCHEM S.R.L.
MTS? (MIC Test Strip) Penicillin G 0.002-32 ?g/mL2018-09-14
Liofilchem S. R. L.
MTS Penicillin 0.002- 32 µg/mL2018-09-13
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS?(MIC Test Strip) Plazomicin 0.016-256 ?g/mL2018-08-03
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS?(MIC Test Strip) Plazomicin 0.016-256 ?g/mL2018-08-03
LIOFILCHEM S.R.L.
MTS?(MIC Test Strip) Plazomicin 0.016-256 ?g/mL2018-08-03
Liofilchem S. R. L.
MTS Plazomicin 0.016-256 µg/mL2018-07-31
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Delafloxacin 0.002-32 ?g/mL2018-05-22
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Delafloxacin 0.002-32 ?g/mL2018-05-22
LIOFILCHEM S.R.L.
MTS? (MIC Test Strip) Delafloxacin 0.002-32 ?g/mL2018-05-22
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Ceftazidime-avibactam 0.016/4-256/4 ?g/mL2018-05-22
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Ceftazidime-avibactam 0.016/4-256/4 ?g/mL2018-05-22
LIOFILCHEM S.R.L.
MTS? (MIC Test Strip) Ceftazidime-avibactam 0.016/4-256/4 ?g/mL2018-05-22
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Tedizolid 0.002-32 ?g/mL2018-05-22
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Tedizolid 0.002-32 ?g/mL2018-05-22
LIOFILCHEM S.R.L.
MTS? (MIC Test Strip) Tedizolid 0.002-32 ?g/mL2018-05-22
Liofilchem S. R. L.
Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 Ug/mL2018-05-18
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Azithromycin 0.016-256 ?g/mL2018-04-05
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Azithromycin 0.016-256 ?g/mL2018-04-05
LIOFILCHEM S.R.L.
MTS? (MIC Test Strip) Azithromycin 0.016-256 ?g/mL2018-04-05
Liofilchem S. R. L.
Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL2018-04-04
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Linezolid 0.016-256 ?g/mL2018-04-04
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Linezolid 0.016-256 ?g/mL2018-04-04
LIOFILCHEM S.R.L.
MTS? (MIC Test Strip) Linezolid 0.016-256 ?g/mL2018-04-04
Liofilchem S. R. L.
Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL2018-03-15
Liofilchem S. R. L.
Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL2018-02-28
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Meropenem-vaborbactam 0.016/8-256/8 ?g/mL2017-12-20
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Meropenem-vaborbactam 0.016/8-256/8 ?g/mL2017-12-20
LIOFILCHEM S.R.L.
MTS? (MIC Test Strip) Meropenem-vaborbactam 0.016/8-256/8 ?g/mL2017-12-20
Liofilchem S. R. L.
Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL2017-12-19
Liofilchem S. R. L.
Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 Mg/mL.2017-10-23
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS? ( MIC Test Strip) Erythromycin 0.016-256 ?g/mL2017-09-28
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS? ( MIC Test Strip) Erythromycin 0.016-256 ?g/mL2017-09-28
LIOFILCHEM S.R.L.
MTS? ( MIC Test Strip) Erythromycin 0.016-256 ?g/mL2017-09-28
Liofilchem S. R. L.
Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL2017-09-27
Liofilchem S. R. L.
Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL2017-08-01
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Delafloxacin 0.002-32 ?g/mL2017-08-01
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Delafloxacin 0.002-32 ?g/mL2017-08-01
LIOFILCHEM S.R.L.
MTS? (MIC Test Strip) Delafloxacin 0.002-32 ?g/mL2017-08-01
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Tedizolid 0.002-32 ?g/mL2017-06-13
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Tedizolid 0.002-32 ?g/mL2017-06-13
LIOFILCHEM S.R.L.
MTS? (MIC Test Strip) Tedizolid 0.002-32 ?g/mL2017-06-13
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Clindamycin 0.016-256 ?g/mL2017-06-13
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Clindamycin 0.016-256 ?g/mL2017-06-13
LIOFILCHEM S.R.L.
MTS? (MIC Test Strip) Clindamycin 0.016-256 ?g/mL2017-06-13
Liofilchem S.r.l.
Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL2017-06-07
Liofilchem S. R. L.
Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL2017-05-25
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Telavancin 0.016-256 ?g/mL2017-03-24
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Telavancin 0.016-256 ?g/mL2017-03-24
LIOFILCHEM S.R.L.
MTS? (MIC Test Strip) Telavancin 0.016-256 ?g/mL2017-03-24
LIOFILCHEM S.R.L.
Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL2017-03-14
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Ceftazidime 0.016-256 ?g/mL2017-02-27
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Ceftazidime 0.016-256 ?g/mL2017-02-27
LIOFILCHEM S.R.L.
MTS? (MIC Test Strip) Ceftazidime 0.016-256 ?g/mL2017-02-27
Liofilchem S. R. L.
Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL2017-02-22
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Meropenem 0.002-32 ?g/mL2017-01-19
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Meropenem 0.002-32 ?g/mL2017-01-19
LIOFILCHEM S.R.L.
MTS? (MIC Test Strip) Meropenem 0.002-32 ?g/mL2017-01-19
Liofilchem S.r.l.
Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 Ug/ml2016-12-19
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Ceftolozane-tazobactam 0.016/4-256/4 ?g/mL2016-08-29
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Ceftolozane-tazobactam 0.016/4-256/4 ?g/mL2016-08-29
LIOFILCHEM S.R.L.
MTS? (MIC Test Strip) Ceftolozane-tazobactam 0.016/4-256/4 ?g/mL2016-08-29
LIOFILCHEM S.R.L.
Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 Mcg/mL2016-07-12
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Vancomycin 0.016-256 ?g/mL2016-06-30
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Vancomycin 0.016-256 ?g/mL2016-06-30
LIOFILCHEM S.R.L.
MTS? (MIC Test Strip) Vancomycin 0.016-256 ?g/mL2016-06-30
Liofilchem, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Dalbavancin 0.002-32 ?g/mL2016-06-30
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS? (MIC Test Strip) Dalbavancin 0.002-32 ?g/mL2016-06-30
LIOFILCHEM S.R.L.
MTS? (MIC Test Strip) Dalbavancin 0.002-32 ?g/mL2016-06-30
LIOFILCHEM S.R.L
Liofilchem MIC Test Strip (MTS) -Dalbavancin At 0.002 - 32 Ug/ml2016-06-22
Liofilchem S.r.l
Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 Ug/mL2016-03-31

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091655751Livorno,Italy -> New York, New YorkMEDICAL COMPONENTS11 CTN

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