Ceftobiprole BPR 5 µg Disc
Liofilchem, Inc.
Liofilchem
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012389632 | 3012389632 | LIOFILCHEM S.R.L. | 1 | N | 2026-01-01 | Via Scozia, Zona Industriale Roseto degli Abruzzi Teramo IT 64026 |
| 3013661582 | 3013661582 | Liofilchem, Inc. | 1 | Y | 2026-01-01 | 465 Waverley Oaks Rd. Suite 317 Waltham MA US 02452 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 212624 | 1028362354 | K260696 | MTS Gepotidacin 0.016-256 µg/mL | JWY | 2026-04-17 |
| 196334 | 1028362354 | K260696 | MTS Gepotidacin 0.016-256 µg/mL | JWY | 2026-04-17 |
| 212624 | 1438176896 | K252114 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL | JWY | 2025-10-02 |
| 196334 | 1438176896 | K252114 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL | JWY | 2025-10-02 |
| 212624 | 1136344472 | K251879 | Sulopenem SPM 2 µg | JTN | 2025-08-12 |
| 196334 | 1136344472 | K251879 | Sulopenem SPM 2 µg | JTN | 2025-08-12 |
| 212624 | 1468028385 | K251580 | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) | JWY | 2025-08-20 |
| 196334 | 1468028385 | K251580 | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) | JWY | 2025-08-20 |
| 212624 | 2048503317 | K250885 | Ceftobiprole BPR 5 µg Disc | JTN | 2025-06-23 |
| 196334 | 2048503317 | K250885 | Ceftobiprole BPR 5 µg Disc | JTN | 2025-06-23 |
| 212624 | 1238633841 | K243202 | MTS Ceftobiprole 0.002-32 µg/mL | JWY | 2025-01-30 |
| 196334 | 1238633841 | K243202 | MTS Ceftobiprole 0.002-32 µg/mL | JWY | 2025-01-30 |
| 196334 | 1026996215 | K230479 | ComASP Cefiderocol 0.008-128 | JWY | 2023-05-18 |
| 212624 | 1026996215 | K230479 | ComASP Cefiderocol 0.008-128 | JWY | 2023-05-18 |
| 212624 | 1108320101 | K211672 | MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL | JWY | 2021-10-20 |
| 196334 | 1108320101 | K211672 | MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL | JWY | 2021-10-20 |
| 196334 | 2060326501 | K200308 | MTS Lefamulin 0.016- 256 µg/mL | JWY | 2020-04-06 |
| 212624 | 2060326501 | K200308 | MTS Lefamulin 0.016- 256 µg/mL | JWY | 2020-04-06 |
| 212624 | 1491981431 | K192345 | MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL | JWY | 2019-10-31 |
| 196334 | 1491981431 | K192345 | MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL | JWY | 2019-10-31 |
| 196334 | 1525239630 | K191908 | MTS Imipenem 0.016-256 µg/mL | JWY | 2019-09-04 |
| 212624 | 1525239630 | K191908 | MTS Imipenem 0.016-256 µg/mL | JWY | 2019-09-04 |
| 196334 | 1807323288 | K191809 | MTS Imipenem-relebactam 0.002/4-32/4 µg/mL | JWY | 2019-08-23 |
| 212624 | 1807323288 | K191809 | MTS Imipenem-relebactam 0.002/4-32/4 µg/mL | JWY | 2019-08-23 |
| 196334 | 1125284381 | K190914 | MTS Doxycycline 0.016 - 256 µg/mL | JWY | 2019-05-29 |
| 212624 | 1125284381 | K190914 | MTS Doxycycline 0.016 - 256 µg/mL | JWY | 2019-05-29 |
| 196334 | 1963302993 | K190252 | MTS Gentamicin 0.016 - 256 µg/mL | JWY | 2019-03-22 |
| 212624 | 1963302993 | K190252 | MTS Gentamicin 0.016 - 256 µg/mL | JWY | 2019-03-22 |
| 196334 | 1500561138 | K183527 | MTS Ciprofloxacin 0.002 - 32 µg/mL | JWY | 2019-03-19 |
| 212624 | 1500561138 | K183527 | MTS Ciprofloxacin 0.002 - 32 µg/mL | JWY | 2019-03-19 |
| 212624 | 1076208283 | K183140 | MTS Tetracycline 0.016 - 256 ug/mL | JWY | 2019-01-11 |
| 196334 | 1076208283 | K183140 | MTS Tetracycline 0.016 - 256 ug/mL | JWY | 2019-01-11 |
| 212624 | 2048107894 | K183115 | MTS Levofloxacin 0.002 - 32 µg/mL | JWY | 2018-12-20 |
| 196334 | 2048107894 | K183115 | MTS Levofloxacin 0.002 - 32 µg/mL | JWY | 2018-12-20 |
| 212624 | 1486313368 | K182922 | MTS Omadacycline 0.002-32 µg/mL | JWY | 2018-12-14 |
| 196334 | 1486313368 | K182922 | MTS Omadacycline 0.002-32 µg/mL | JWY | 2018-12-14 |
| 212624 | 1607200106 | K182557 | MTS Eravacycline 0.002 - 32 µg/mL | JWY | 2018-11-02 |
| 196334 | 1607200106 | K182557 | MTS Eravacycline 0.002 - 32 µg/mL | JWY | 2018-11-02 |
| 212624 | 1479365012 | K181889 | MTS Penicillin 0.002- 32 µg/mL | JWY | 2018-09-13 |
| 196334 | 1479365012 | K181889 | MTS Penicillin 0.002- 32 µg/mL | JWY | 2018-09-13 |
| 196334 | 1516525624 | K181708 | MTS Plazomicin 0.016-256 µg/mL | JWY | 2018-07-31 |
| 212624 | 1516525624 | K181708 | MTS Plazomicin 0.016-256 µg/mL | JWY | 2018-07-31 |
| 196334 | 1836442240 | K180886 | Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL | JWY | 2018-05-18 |
| 212624 | 1836442240 | K180886 | Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL | JWY | 2018-05-18 |
| 212624 | 1942941773 | K180339 | Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL | JWY | 2018-04-04 |
| 196334 | 1942941773 | K180339 | Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL | JWY | 2018-04-04 |
| 212624 | 1859005205 | K180330 | Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL | JWY | 2018-03-15 |
| 196334 | 1859005205 | K180330 | Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL | JWY | 2018-03-15 |
| 212624 | 1857985575 | K173817 | Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL | JWY | 2018-02-28 |
| 196334 | 1857985575 | K173817 | Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL | JWY | 2018-02-28 |
| 196334 | 1175429910 | K173307 | Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL | JWY | 2017-12-19 |
| 212624 | 1175429910 | K173307 | Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL | JWY | 2017-12-19 |
| 212624 | 1549567676 | K172542 | Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL. | JWY | 2017-10-23 |
| 196334 | 1549567676 | K172542 | Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL. | JWY | 2017-10-23 |
| 196334 | 1205347853 | K172109 | Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL | JWY | 2017-09-27 |
| 212624 | 1205347853 | K172109 | Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL | JWY | 2017-09-27 |
| 212624 | 1454380141 | K171906 | Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL | JWY | 2017-08-01 |
| 196334 | 1454380141 | K171906 | Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL | JWY | 2017-08-01 |
| 212624 | 1198162733 | K170892 | Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL | JWY | 2017-05-25 |
| 196334 | 1198162733 | K170892 | Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL | JWY | 2017-05-25 |
| 212624 | 1293944412 | K170772 | Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL | JWY | 2017-06-07 |
| 196334 | 1293944412 | K170772 | Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL | JWY | 2017-06-07 |
| 212624 | 1852845626 | K163517 | Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL | JWY | 2017-03-14 |
| 196334 | 1852845626 | K163517 | Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL | JWY | 2017-03-14 |
| 212624 | 1465717422 | K163298 | Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL | JWY | 2017-02-22 |
| 196334 | 1465717422 | K163298 | Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL | JWY | 2017-02-22 |
| 212624 | 1049340622 | K162854 | Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml | JWY | 2016-12-19 |
| 196334 | 1049340622 | K162854 | Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml | JWY | 2016-12-19 |
| 212624 | 1056732746 | K161175 | Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL | JWY | 2016-07-12 |
| 196334 | 1056732746 | K161175 | Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL | JWY | 2016-07-12 |
| 212624 | 1641420750 | K153687 | Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL | JWY | 2016-03-31 |
| 196334 | 1641420750 | K153687 | Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL | JWY | 2016-03-31 |
| 212624 | 1470644990 | K153569 | Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml | JWY | 2016-06-22 |
| 196334 | 1470644990 | K153569 | Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml | JWY | 2016-06-22 |
| 196334 | 1561891198 | ||||
| 212624 | 1561891198 | ||||
| 196334 | 2056863346 | ||||
| 212624 | 2056863346 |
Product Codes Associated With Registrations#
PMN#
MTS Ceftobiprole 0.002-32 µg/mL
Liofilchem s.r.l.
ComASP Cefiderocol 0.008-128
Liofilchem s.r.l.
MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL
Liofilchem S. R. L.
MTS Lefamulin 0.016- 256 µg/mL
Liofilchem S. R. 1.
MTS Omadacycline 0.002 - 32 Ug/mL
Liofilchem S. R. L.
MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL
Liofilchem S. R. L.
MTS Imipenem 0.016-256 µg/mL
Liofilchem S.r.l.
MTS Imipenem-relebactam 0.002/4-32/4 µg/mL
Liofilchem S. R. L.
MTS Doxycycline 0.016 - 256 µg/mL
Liofilchem S. R. L.
MTS Gentamicin 0.016 - 256 µg/mL
Liofilchem S. R. L.
MTS Ciprofloxacin 0.002 - 32 µg/mL
Liofilchem S. R. L.
MTS Tetracycline 0.016 - 256 Ug/mL
Liofilchem S.r.l.
MTS Levofloxacin 0.002 - 32 µg/mL
Liofilchem S. R. L.
MTS Omadacycline 0.002-32 µg/mL
Liofilchem S. R. L.
MTS Eravacycline 0.002 - 32 µg/mL
Liofilchem s.r.l.
MTS Penicillin 0.002- 32 µg/mL
Liofilchem S. R. L.
MTS Plazomicin 0.016-256 µg/mL
Liofilchem S. R. L.
Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 Ug/mL
Liofilchem S. R. L.
Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL
Liofilchem S. R. L.
Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL
Liofilchem S. R. L.
Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL
Liofilchem S. R. L.
Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL
Liofilchem S. R. L.
Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 Mg/mL.
Liofilchem S. R. L.
Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL
Liofilchem S. R. L.
Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL
Liofilchem S. R. L.
Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL
Liofilchem S.r.l.
Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL
Liofilchem S. R. L.
Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL
LIOFILCHEM S.R.L.
Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL
Liofilchem S. R. L.
Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 Ug/ml
Liofilchem S.r.l.
Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 Mcg/mL
LIOFILCHEM S.R.L.
Liofilchem MIC Test Strip (MTS) -Dalbavancin At 0.002 - 32 Ug/ml
LIOFILCHEM S.R.L
Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 Ug/mL
Liofilchem S.r.l
GUDID#
Liofilchem MTS (MIC Test Strip) - Gepotidacin GEP 0.016-256
2026-05-22
Liofilchem MTS (MIC Test Strip) - Gepotidacin GEP 0.016-256
2026-05-22
Liofilchem Antibiotic Disc - Ceftobiprole BPR 5 µg
2025-07-15
Liofilchem Antibiotic Disc - Ceftobiprole BPR 5 µg
2025-07-15
Liofilchem MTS (MIC Test Strip) - Ceftobiprole 0.002-32 µg/mL, 1 Strip
2025-03-19
Liofilchem MTS (MIC Test Strip) - Ceftobiprole 0.002-32 µg/mL, 1 Strip
2025-03-19
ComASP - ComASP Cefiderocol 0.008-128
2023-05-31
Liofilchem MTS (MIC Test Strip) - LEVOFLOXACIN LEV 0.002-32 100 MTS canister
2022-01-28
Liofilchem MTS (MIC Test Strip) - PENICILLIN G P 0.002-32 100 MTS canister
2022-01-28
Liofilchem MTS (MIC Test Strip) - Imipenem-relebactam I/R 0.002/4-32/4 1400 MTS cani
2022-01-28
Liofilchem MTS (MIC Test Strip) - Omadacycline OMC 0.002-32 100 MTS canister
2022-01-28
Liofilchem MTS (MIC Test Strip) - Plazomicin PLZ 0.016-256 100 MTS canister
2022-01-28
Liofilchem MTS (MIC Test Strip) - Imipenem IMI 0.016-256 100 MTS canister
2022-01-28
Liofilchem MTS (MIC Test Strip) - Lefamulin LMU 0.016-256 100 MTS canister
2022-01-28
Liofilchem MTS (MIC Test Strip) - CIPROFLOXACIN CIP 0.002-32 100 MTS canister
2022-01-28
Liofilchem MTS (MIC Test Strip) - AZITHROMYCIN AZM 0.016-256 100 MTS canister
2022-01-28
Liofilchem MTS (MIC Test Strip) - Ampicillin*-sulbactam AMS 0.016/0.008-256/128 100
2022-01-28
Liofilchem MTS (MIC Test Strip) - GENTAMICIN CN 0.016-256 100 MTS canister
2022-01-28
Liofilchem MTS (MIC Test Strip) - Meropenem-vaborbactam M/V 0.016/8-256/8
2022-01-28
Liofilchem MTS (MIC Test Strip) - ERYTHROMYCIN E 0.016-256 100 MTS canister
2022-01-28
Liofilchem MTS (MIC Test Strip) - Delafloxacin DLX 0.002-32 100 MTS canister
2022-01-28
Liofilchem MTS (MIC Test Strip) - TELAVANCIN TLV 0.016-256 100 MTS Canister
2022-01-28
Liofilchem MTS (MIC Test Strip) - CEFTAZIDIME CAZ 0,016-256 100 MTS canister
2022-01-28
Liofilchem MTS (MIC Test Strip) - TEDIZOLID TZD 0.002-32 100 MTS Canister
2022-01-28
Liofilchem MTS (MIC Test Strip) - Clindamycin CD 0.016-256 100 MTS canister
2022-01-28
Liofilchem MTS (MIC Test Strip) - ERAVACYCLINE ERV 0.002-32 100 MTS canister
2022-01-28
Liofilchem MTS (MIC Test Strip) - TETRACYCLINE TE 0.016-256 100 MTS canister
2022-01-28
Liofilchem MTS (MIC Test Strip) - LINEZOLID LNZ 0.016-256 100 MTS canister
2022-01-28
Liofilchem MTS (MIC Test Strip) - Ceftazidime-avibactam CZA 0.016/4-256/4 100 MTS ca
2022-01-28
Liofilchem MTS (MIC Test Strip) - DOXYCYCLINE DXT 0.016-256 100 MTS canister
2022-01-28
Liofilchem MTS (MIC Test Strip) - Dalbavancin DAL 0.002-32 100 Strip Canister
2022-01-27
Liofilchem MTS (MIC Test Strip) - VANCOMYCIN VA 0.016-256 100 Strip Canister
2022-01-27
Liofilchem MTS (MIC Test Strip) - Ceftolozane-tazobactam C/T 0.016/4 - 256/4 100 Str
2022-01-27
Liofilchem MTS (MIC Test Strip) - MEROPENEM MRP 0.002-32 100 Strip Canister
2022-01-27
Liofilchem MTS (MIC Test Strip) - Piperacillin*- tazobactam TZP 0.016-256*
2021-10-27
Liofilchem MTS (MIC Test Strip) - Piperacillin*- tazobactam TZP 0.016-256*
2021-10-27
Liofilchem MTS (MIC Test Strip) - Lefamulin LMU 0.016-256 µg/ml, 1 Strip
2020-05-15
Liofilchem MTS (MIC Test Strip) - Lefamulin LMU 0.016-256 µg/ml, 1 Strip
2020-05-15
Liofilchem Mic Test Strip (MTS) - Omadacycline 0.002-32 µg/mL, 1 Strip
2019-01-31
Liofilchem Mic Test Strip (MTS) - Omadacycline 0.002-32 µg/mL, 10 Strip
2019-01-31