This page includes the latest FDA filings for Institut Virion Serion G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3010194607 |
| FEI Number | 3010194607 |
| Name | Mark A. Kowal |
| Owner & Operator | Institut Virion\Serion GmbH |
| Contact Address | Friedrich-Bergius-Ring 19 W?rzburg DE-BY Bayern 97076 DE |
| Official Correspondent |
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| US Agent |
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| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 8201 Central Ave NE Suite P Minneapolis, MN 55432 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
Mark A. Kowal [Institut Virion\Serion GmbH] | Serion CFT EchoVirus Pool Control Antigen | 2018-12-04 |
Mark A. Kowal [Institut Virion\Serion GmbH] | Serion CFT EchoVirus Pool Antigen | 2018-12-04 |
Mark A. Kowal [Institut Virion\Serion GmbH] | SERION CFT EchoVirus Pool Positive Control Serum | 2018-12-04 |
Mark A. Kowal [Institut Virion\Serion GmbH] | SERION CFT EchoVirus Pool Negative Control Serum | 2018-12-04 |
Mark A. Kowal [Institut Virion\Serion GmbH] | ROTAVIRUS Positive Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | ROTAVIRUS Negative Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | ROTAVIRUS Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | LEGIONELLA PNEUMOPHILA Positive Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | LEGIONELLA PNEUMOPHILA Negative Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | LEGIONELLA PNEUMOPHILA Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | Hemolytic amboceptor | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | Complement | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | CFT-Buffer | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | LISTERIA MONOCYTOGENES Positive Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | LISTERIA MONOCYTOGENES Negative Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | LISTERIA MONOCYTOGENES Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | MYCOPLASMA PNEUMONIAE Positive Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | MYCOPLASMA PNEUMONIAE Negative Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | MYCOPLASMA PNEUMONIAE Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | MEASLES VIRUS Positive Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | MEASLES VIRUS Negative Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | MEASLES VIRUS Control Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | MEASLES VIRUS Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | MUMPS VIRUS (PAROTITIS VIRUS) Positive Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | MUMPS VIRUS (PAROTITIS VIRUS) Negative Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | MUMPS VIRUS (PAROTITIS VIRUS) Control Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | MUMPS VIRUS (PAROTITIS VIRUS) Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | PARAINFLUENZA VIRUS POOL (1, 2, 3) Positive Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | PARAINFLUENZA VIRUS POOL (1, 2, 3) Negative Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | PARAINFLUENZA VIRUS POOL (1, 2, 3) Control Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | PARAINFLUENZA VIRUS POOL (1, 2, 3) Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | PARAINFLUENZA VIRUS 3 Positive Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | PARAINFLUENZA VIRUS 3 Negative Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | PARAINFLUENZA VIRUS 3 Control Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | PARAINFLUENZA VIRUS 3 Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | PARAINFLUENZA VIRUS 2 Positive Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | PARAINFLUENZA VIRUS 2 Negative Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | PARAINFLUENZA VIRUS 2 Control Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | PARAINFLUENZA VIRUS 2 Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | PARAINFLUENZA VIRUS 1 Positive Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | PARAINFLUENZA VIRUS 1 Negative Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | PARAINFLUENZA VIRUS 1 Control Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | PARAINFLUENZA VIRUS 1 Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | RESPIRATORY SYNCYTIAL VIRUS Positive Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | RESPIRATORY SYNCYTIAL VIRUS Negative Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | RESPIRATORY SYNCYTIAL VIRUS Control Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | RESPIRATORY SYNCYTIAL VIRUS Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXIELLA BURNETII (Q-FEVER) PHASE 2 Positive Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXIELLA BURNETII (Q-FEVER) PHASE 2 Negative Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXIELLA BURNETII (Q-FEVER) PHASE 2 Control Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXIELLA BURNETII (Q-FEVER) PHASE 2 Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXIELLA BURNETII (Q-FEVER) PHASE 1 Positive Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXIELLA BURNETII (Q-FEVER) PHASE 1 Negative Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXIELLA BURNETII (Q-FEVER) PHASE 1 Control Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXIELLA BURNETII (Q-FEVER) PHASE 1 Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | POLIO VIRUS Positive Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | POLIO VIRUS Negative Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | POLIO VIRUS Control Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | POLIO VIRUS Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | ADENOVIRUS Positive Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | ADENOVIRUS Negative Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | ADENOVIRUS Control Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | ADENOVIRUS Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | INFLUENZA B VIRUS Positive Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | INFLUENZA B VIRUS Negative Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | INFLUENZA B VIRUS Control Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | INFLUENZA B VIRUS Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | INFLUENZA A/B VIRUS POOL Positive Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | INFLUENZA A/B VIRUS POOL Negative Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | INFLUENZA A/B VIRUS POOL Control Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | INFLUENZA A/B VIRUS POOL Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | INFLUENZA A VIRUS Positive Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | INFLUENZA A VIRUS Negative Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | INFLUENZA A VIRUS Control Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | INFLUENZA A VIRUS Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIEVIRUS control antigen (B1-B6) | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIEVIRUS B6 Positive Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIEVIRUS B6 Negative Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIEVIRUS B6 Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIEVIRUS B5 Positive Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIEVIRUS B5 Negative Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIEVIRUS B5 Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIEVIRUS B4Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIEVIRUS B4 Positive Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIEVIRUS B4 Negative Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIEVIRUS B3 Positive Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIEVIRUS B3 Negative Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIEVIRUS B3 Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIEVIRUS B2 Positive Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIEVIRUS B2 Negative Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIEVIRUS B2 Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIEVIRUS B1 Positive Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIEVIRUS B1 Negative Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIEVIRUS B1 Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIEVIRUS A9 Positive Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIEVIRUS A9 Negative Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIEVIRUS A9 Control Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIEVIRUS A9 Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIE POOL (A9, B1-6) Positive Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIE POOL (A9, B1-6) Negative Control Serum | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIE POOL (A9, B1-6) Control Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | COXSACKIE POOL (A9, B1-6) Antigen | 2015-04-09 |
Mark A. Kowal [Institut Virion\Serion GmbH] | BRUCELLA Positive Control Serum | 2013-03-22 |
Mark A. Kowal [Institut Virion\Serion GmbH] | BRUCELLA Negative Control Serum | 2013-03-22 |
Mark A. Kowal [Institut Virion\Serion GmbH] | BRUCELLA Antigen | 2013-03-22 |
Mark A. Kowal [Institut Virion\Serion GmbH] | LEPTOSPIRA SEJROE Antigen | 2013-03-22 |
Mark A. Kowal [Institut Virion\Serion GmbH] | LEPTOSPIRA Positive Control Serum | 2013-03-22 |
Mark A. Kowal [Institut Virion\Serion GmbH] | LEPTOSPIRA POMONA Antigen | 2013-03-22 |
Mark A. Kowal [Institut Virion\Serion GmbH] | LEPTOSPIRA Negative Control Serum | 2013-03-22 |
Mark A. Kowal [Institut Virion\Serion GmbH] | LEPTOSPIRA ICTEROHAEMORRHAGIAE Antigen | 2013-03-22 |
Mark A. Kowal [Institut Virion\Serion GmbH] | LEPTOSPIRA GRIPPOTYPHOSA Antigen | 2013-03-22 |
Mark A. Kowal [Institut Virion\Serion GmbH] | LEPTOSPIRA CANICOLA Antigen | 2013-03-22 |
Mark A. Kowal [Institut Virion\Serion GmbH] | LEPTOSPIRA (BIFLEXA) Positive Control Serum | 2013-03-22 |
Mark A. Kowal [Institut Virion\Serion GmbH] | LEPTOSPIRA (BIFLEXA) Antigen | 2013-03-22 |
| NCAGE Code | CA064 | INSTITUT VIRION SERION GMBH |
| CAGE Code | CA064 | INSTITUT VIRION SERION GMBH |