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
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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