This page includes the latest FDA filings for Access Bio Incorporate. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3003966368 |
| FEI Number | 3008474767 |
| Name | ACCESS BIO INCORPORATE |
| Owner & Operator | ACCESS BIO INCORPORATE |
| Contact Address | 65 Clyde Rd. Suite A Somerset NJ 08873 US |
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 65 Clyde Rd Ste A Somerset, NJ 08873 US |
| Establishment Type |
|
Device Company | Device | Date |
|---|---|---|
ACCESS BIO INCORPORATE | CareStartTM Influenza A & B RDT | 2018-11-27 |
ACCESS BIO INCORPORATE | CareStartTM Flu A & B Plus | 2018-11-27 |
ACCESS BIO INCORPORATE | CareStart? Strep A | 2016-03-16 |
ACCESS BIO INCORPORATE | CareStart? Strep A Plus | 2016-03-16 |
ACCESS BIO INCORPORATE | CareStart? RSV | 2016-03-16 |
ACCESS BIO INCORPORATE | CareStartTM Dengue NS1 | 2015-08-06 |
ACCESS BIO INCORPORATE | CareStartTM Dengue IgM/IgG | 2015-08-06 |
ACCESS BIO INCORPORATE | CareStartTM Dengue Combo NS1 & IgM/IgG | 2015-08-06 |
ACCESS BIO INCORPORATE | CareStart G6PD | 2012-10-16 |
ACCESS BIO INCORPORATE | ppslC00001 | 2011-05-11 |
ACCESS BIO INCORPORATE | CareStart Malaria/Pregnancy Combo (HRP2/pLDH/HCG) | 2010-08-16 |
ACCESS BIO INCORPORATE | CareStart Malaria pLDH (Pf/PAN) | 2010-08-16 |
ACCESS BIO INCORPORATE | CareStart Malaria pLDH (Pf) | 2010-08-16 |
ACCESS BIO INCORPORATE | CareStart Malaria pLDH (PAN) | 2010-08-16 |
ACCESS BIO INCORPORATE | CareStart Malaria Screen | 2010-08-16 |
ACCESS BIO INCORPORATE | CareStart Malaria HRP2/pLDH (Pf/VOM) Combo | 2010-08-16 |
ACCESS BIO INCORPORATE | CareStart Malaria HRP2/pLDH (Pf/Pv) Combo | 2010-08-16 |
ACCESS BIO INCORPORATE | CareStart Malaria HRP2/pLDH (Pf/PAN) Combo | 2010-08-16 |
ACCESS BIO INCORPORATE | CareStart Malaria HRP2/pLDH (Pf) | 2010-08-16 |
ACCESS BIO INCORPORATE | CareStart Malaria HRP2 (Pf) | 2010-08-16 |
ACCESS BIO INCORPORATE | CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN | 2005-11-29 |
ACCESS BIO INCORPORATE | CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST | 2003-06-16 |
ACCESS BIO INCORPORATE | CARESTART HCG ONE-STEP PREGNANCY TEST | 2003-06-13 |