This page includes the latest FDA filings for Liofilchem Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3013661582 |
| FEI Number | 3013661582 |
| Name | Liofilchem, Inc. |
| Owner & Operator | Liofilchem S.R.L. |
| Contact Address | Via Scozia, Zona Industriale Roseto degli Abruzzi IT-TE Teramo 64026 IT |
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 465 Waverley Oaks Rd. Suite 317 Waltham, MA 02452 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS Lefamulin 0.016-256 ug/mL | 2020-04-07 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS Ampicillin-sulbactam 0.016/0.008-256/128 ug/mL | 2019-11-01 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS Imipenem 0.016 - 256 ug/mL | 2019-09-06 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS Imipenem-relebactam 0.002/4 - 32/4 ug/mL | 2019-08-23 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS Doxycycline 0.016-256 ug/mL | 2019-05-30 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS Gentamicin 0.016 - 256 ug/mL | 2019-03-22 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS Ciprofloxacin 0.002 - 32 ug/mL | 2019-03-20 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS Tetracycline 0.016 - 256 ug/mL | 2019-01-11 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS?Levofloxacin 0.002-32 ug/mL | 2018-12-21 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS? (MIC Test Strip) Omadacycline 0.002-32 ?g/mL | 2018-12-14 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS? (MIC Test Strip) Eravacycline 0.002-32 ?g/mL | 2018-11-02 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS? (MIC Test Strip) Penicillin G 0.002-32 ?g/mL | 2018-09-14 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS?(MIC Test Strip) Plazomicin 0.016-256 ?g/mL | 2018-08-03 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS? (MIC Test Strip) Delafloxacin 0.002-32 ?g/mL | 2018-05-22 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS? (MIC Test Strip) Ceftazidime-avibactam 0.016/4-256/4 ?g/mL | 2018-05-22 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS? (MIC Test Strip) Tedizolid 0.002-32 ?g/mL | 2018-05-22 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS? (MIC Test Strip) Azithromycin 0.016-256 ?g/mL | 2018-04-05 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS? (MIC Test Strip) Linezolid 0.016-256 ?g/mL | 2018-04-04 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS? (MIC Test Strip) Meropenem-vaborbactam 0.016/8-256/8 ?g/mL | 2017-12-20 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS? ( MIC Test Strip) Erythromycin 0.016-256 ?g/mL | 2017-09-28 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS? (MIC Test Strip) Delafloxacin 0.002-32 ?g/mL | 2017-08-01 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS? (MIC Test Strip) Tedizolid 0.002-32 ?g/mL | 2017-06-13 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS? (MIC Test Strip) Clindamycin 0.016-256 ?g/mL | 2017-06-13 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS? (MIC Test Strip) Telavancin 0.016-256 ?g/mL | 2017-03-24 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS? (MIC Test Strip) Ceftazidime 0.016-256 ?g/mL | 2017-02-27 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS? (MIC Test Strip) Meropenem 0.002-32 ?g/mL | 2017-01-19 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS? (MIC Test Strip) Ceftolozane-tazobactam 0.016/4-256/4 ?g/mL | 2016-08-29 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS? (MIC Test Strip) Vancomycin 0.016-256 ?g/mL | 2016-06-30 |
Liofilchem, Inc. [Liofilchem S.R.L.] | MTS? (MIC Test Strip) Dalbavancin 0.002-32 ?g/mL | 2016-06-30 |
| NCAGE Code | 80L13 | LIOFILCHEM, INC |
| CAGE Code | 80L13 | LIOFILCHEM, INC |
| S.A.M. Registration | 80L13 [80898462] | LIOFILCHEM, INC |