This page includes the latest FDA filings for Seracare Life Sciences Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3007088335 |
| FEI Number | 1220394 |
| Name | SERACARE LIFE SCIENCES, INC |
| Owner & Operator | SERACARE LIFE SCIENCES, INC |
| Contact Address | 37 Birch Street -- Milford MA 01757 US |
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 37 Birch St Milford, MA 01757 US |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| SERACARE LIFE SCIENCES, INC. | ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 6 x 3.5 mL | 2021-08-26 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 1 x 5.0 mL | 2021-08-26 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® Anti-SARS-CoV-2 Controls Kit Series 2000 | 2020-12-11 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® Anti-SARS-CoV-2 Controls Kit Series 1000 | 2020-12-11 |
| SERACARE LIFE SCIENCES, INC. | AccuPlex SARS-CoV-2 Molecular Controls Kit – Full Genome | 2020-09-29 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 365 Series 200 2020-0107 | 2020-09-01 |
| SERACARE LIFE SCIENCES, INC. | AccuPlex™ SARS-CoV-2 Molecular Controls kit 0505-0133 | 2020-07-17 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2020-0104 | 2020-06-29 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2000-0038 | 2019-02-21 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2035-0009 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2035-0005 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2025-0068 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2025-0067 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2025-0061 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2025-0060 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2025-0043 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2025-0041 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2025-0037 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2015-0097 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2015-0094 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2015-0086 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2015-0084 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2015-0083 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2015-0079 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2015-0078 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2015-0077 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2015-0074 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2015-0073 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2015-0072 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2015-0071 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2015-0070 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2015-0068 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2015-0066 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2015-0065 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2010-0020 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2010-0018 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2000-0043 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2000-0041 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2000-0040 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2000-0039 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2000-0037 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2000-0035 | 2018-10-25 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2000-0034 | 2018-10-25 |
SERACARE LIFE SCIENCES, INC | ACCURUN 119 Anti-Hepatitis B e Antigen (Anti-HBe) Positive Control | 2018-09-24 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2000-0006 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2000-0005 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2020-0093 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2000-0022 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2000-0017 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2000-0016 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2020-0105 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2020-0098 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2020-0096 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2020-0095 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2020-0092 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2020-0090 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2020-0087 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2020-0085 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2020-0083 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2020-0080 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2020-0078 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2015-0093 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2015-0092 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2015-0090 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2015-0088 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2015-0087 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2015-0082 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2010-0015 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2010-0013 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2000-0032 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2000-0018 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2000-0010 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2000-0008 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2000-0002 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2000-0001 | 2018-07-06 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2035-0007 | 2018-03-29 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2015-0081 | 2018-03-29 |
| SERACARE LIFE SCIENCES, INC. | ACCURUN® 2015-0080 | 2018-03-29 |
| SERACARE LIFE SCIENCES, INC. | AccuPlex™ 0505-0001 | 2018-03-29 |
SERACARE LIFE SCIENCES, INC | ACCURUN 106 HIV-1 Antigen Positive Control | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | AccuPlex rEbola GP/NP Reference Material | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 873 HPV DNA Negative Control | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 872 HPV DNA Negative Control | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 841 CT/NG Negative Control | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 810 Multi-Marker Negative Control | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 800 ToRCH Negative Control | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 52 Multi-Marker Hepatitis Positive Control 2 | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 51 Multi-Marker Hepatitis Positive Control 1 | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 501 C. difficile Control | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 40 Anti-Measles, Mumps, Rubella, VZV Positive Control Series 5000 | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 381 HPV Type 16 and 18 Positive Control | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 378 HPV DNA Positive Control Series 5000 | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 372 HPV DNA Positive Control Series 600 | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 372 HPV DNA Positive Control Series 400 | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 700 | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 100 | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 31 EBV IgM Positive Control | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 30 EBV IgG Positive Control | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 26 ToRC IgM Positive Control Series 5000 | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 25 ToRCH IgG Positive Control | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 190 Chagas Positive Control | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 156 Reagin (Syphilis) Positive Control | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 141 Rubella IgM Positive Control | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 136 Toxoplasma IgM Positive Control | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 127 Anti-Hepatitis Delta Positive Control | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 125 Anti-HBs Positive Control | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 115 Hepatitis B Core IgG Positive Control | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 113 HBc IgM Positive Control | 2016-10-14 |
SERACARE LIFE SCIENCES, INC | ACCURUN 155 Anti-treponema (syphilis) Positive Controls, Series 2000 and Series 5000 | 2016-09-22 |
SERACARE LIFE SCIENCES, INC | ACCURUN 803 Nucleic Acid Negative Control | 2016-09-22 |
SERACARE LIFE SCIENCES, INC | ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Controls | 2016-09-22 |
SERACARE LIFE SCIENCES, INC | ACCURUN 325 HBV DNA Positive Controls | 2016-09-22 |
SERACARE LIFE SCIENCES, INC | ACCURUN 305 HCV RNA Positive Controls | 2016-09-22 |
SERACARE LIFE SCIENCES, INC | ACCURUN 315 HIV-1 RNA Positive Controls | 2016-09-22 |
SERACARE LIFE SCIENCES, INC | ACCURUN 1 Multi Marker Negative Control | 2016-09-22 |
SERACARE LIFE SCIENCES, INC | ACCURUN? 132 Lyme IgM Positive Control | 2015-08-18 |
SERACARE LIFE SCIENCES, INC | ACCURUN? 130 Lyme IgG Positive Control | 2015-08-18 |
SERACARE LIFE SCIENCES, INC | ACCURUN? 121 HAV IgM Positive Control | 2015-08-18 |
SERACARE LIFE SCIENCES, INC | ACCURUN? 120 HAV IgG Positive Control | 2015-08-18 |
SERACARE LIFE SCIENCES, INC | ACCURUN 135 Toxo IgG Pos Control | 2007-12-06 |
SERACARE LIFE SCIENCES, INC | ACCURUN 140 Rubella IgG Pos Control | 2007-12-06 |
SERACARE LIFE SCIENCES, INC | ACCURUN 146 CMV IgM Pos Control | 2007-12-06 |
SERACARE LIFE SCIENCES, INC | ACCURUN 117 HBeAg Positive Control | 2007-12-06 |
SERACARE LIFE SCIENCES, INC | ACCURUN 24 Multi-Marker Confirmatory Control | 2007-12-06 |
SERACARE LIFE SCIENCES, INC | ACCURUN 145 CMV IgG Positive Control | 2007-12-06 |
SERACARE LIFE SCIENCES, INC | ACCURUN 1 Multi-Marker Pos Control | 2007-12-06 |
SERACARE LIFE SCIENCES, INC | ACURUN 365 West nile Virus RNA Positive Quality Control | 2006-12-28 |
| NCAGE Code | 3Y6A3 | SERACARE LIFE SCIENCES, INC.!DBA SERACARE LIFE SCIENCES!DIV SERACARE DIAGNOSTICS, BBI!DIAGNOSTICS |
| CAGE Code | 3Y6A3 | SERACARE LIFE SCIENCES, INC. SERACARE LIFE SCIENCES SERACARE DIAGNOSTICS, BBI DIAGNOSTICS |
| S.A.M. Registration | 3Y6A3 [106267123] | SERACARE LIFE SCIENCES, INC. SERACARE LIFE SCIENCES |
| SEC | 0001156295 | SERACARE LIFE SCIENCES INC |