Laboratory Specialists Inc

FDA Filings

This page includes the latest FDA filings for Laboratory Specialists Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Laboratory Specialists Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
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
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS Lefamulin 0.016-256 ug/mL2020-04-07
Laboratory Specialists, 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 Imipenem 0.016 - 256 ug/mL2019-09-06
Laboratory Specialists, 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 Doxycycline 0.016-256 ug/mL2019-05-30
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS Gentamicin 0.016 - 256 ug/mL2019-03-22
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS Ciprofloxacin 0.002 - 32 ug/mL2019-03-20
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS Tetracycline 0.016 - 256 ug/mL2019-01-11
Laboratory Specialists, Inc. [Liofilchem S.R.L.]
MTS?Levofloxacin 0.002-32 ug/mL2018-12-21
Laboratory Specialists, 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) Eravacycline 0.002-32 ?g/mL2018-11-02
Laboratory Specialists, 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) Plazomicin 0.016-256 ?g/mL2018-08-03
Laboratory Specialists, 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) Ceftazidime-avibactam 0.016/4-256/4 ?g/mL2018-05-22
Laboratory Specialists, 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) Azithromycin 0.016-256 ?g/mL2018-04-05
Laboratory Specialists, 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) Meropenem-vaborbactam 0.016/8-256/8 ?g/mL2017-12-20
Laboratory Specialists, 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) Delafloxacin 0.002-32 ?g/mL2017-08-01
Laboratory Specialists, 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) Clindamycin 0.016-256 ?g/mL2017-06-13
Laboratory Specialists, 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) Ceftazidime 0.016-256 ?g/mL2017-02-27
Laboratory Specialists, 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) Ceftolozane-tazobactam 0.016/4-256/4 ?g/mL2016-08-29
Laboratory Specialists, 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) Dalbavancin 0.002-32 ?g/mL2016-06-30

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