This page includes the latest FDA filings for Biolytical Laboratories Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3003871407 | ||||||
| FEI Number | 3003871407 | ||||||
| Name | Arnie Sherman | ||||||
| Owner & Operator | Biolytical Laboratories Inc. | ||||||
| Contact Address | 1108-13351 Commerce Parkway Richmond CA-BC British Columbia V6V2X7 CA | ||||||
| Official Correspondent |
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| US Agent |
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| Importing Logistics Registration |
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| Importing Logistics Registration |
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| Registration Status | 1 | ||||||
| Initial Importer | N | ||||||
| Registration Expiration | 2020-04-25 | ||||||
| Registration Address | 7310 Broken Bow Cluster Missoula, MT 59808 US | ||||||
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| BioLytical Laboratories Inc | INSTI HIV-1/HIV-2 Control Test Kit 90-1031 | 2020-10-08 |
| BioLytical Laboratories Inc | INSTI HIV-1 Control Test Kit 90-1030 | 2020-10-08 |
| BioLytical Laboratories Inc | INSTI HIV-1/HIV-2 Antibody Test 90-1019 | 2020-10-08 |
| BioLytical Laboratories Inc | INSTI HIV-1/HIV-2 Control Test 90-1031 | 2018-07-06 |
| BioLytical Laboratories Inc | HIV-1 Control Test Kit 90-1030 | 2018-07-06 |
| BioLytical Laboratories Inc | INSTI HIV-1/HIV-2 Antibody Test 90-1020 | 2018-07-06 |
| BioLytical Laboratories Inc | INSTI HIV-1/HIV-2 Antibody Test 90-1019 | 2018-07-06 |
| BioLytical Laboratories Inc | INSTI HIV-1/HIV-2 Antibody Test 90-1018 | 2018-07-06 |
| BioLytical Laboratories Inc | INSTI Test Controls HIV-1 80-1071 | 2018-07-06 |
| BioLytical Laboratories Inc | INSTI HIV-1/HIV-2 Test Controls 80-1037 | 2018-07-06 |
Arnie Sherman [Biolytical Laboratories Inc.] | INSTI HIV-1/HIV-2 Control Test Kit | 2011-09-16 |
Arnie Sherman [Biolytical Laboratories Inc.] | INSTI HIV-1/2 Antibody Test Kit (INSTI) | 2011-09-16 |
Arnie Sherman [Biolytical Laboratories Inc.] | INSTI HIV-1, Control Test Kit | 2011-09-16 |
| NCAGE Code | L6614 | BIOLYTICAL LABORATORIES INC |
| CAGE Code | L6614 | BIOLYTICAL LABORATORIES INC |
| S.A.M. Registration | L6614 [201060071] | BIOLYTICAL LABORATORIES INC |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020052324516 | Shanghai ,China (Mainland) -> Tacoma, Washington | PLASTIC DROPPER | 10 PKG |