Access Bio Incorporate

FDA Filings

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.

FDA Registration(s)

• 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:
  • Repack or Relabel Medical Device
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
PSZ ACCESS BIO INCORPORATE	CareStartTM Influenza A & B RDT	2018-11-27
PSZ ACCESS BIO INCORPORATE	CareStartTM Flu A & B Plus	2018-11-27
GTZ ACCESS BIO INCORPORATE	CareStart? Strep A	2016-03-16
GTZ ACCESS BIO INCORPORATE	CareStart? Strep A Plus	2016-03-16
GQG ACCESS BIO INCORPORATE	CareStart? RSV	2016-03-16
OSU ACCESS BIO INCORPORATE	CareStartTM Dengue NS1	2015-08-06
OSU ACCESS BIO INCORPORATE	CareStartTM Dengue IgM/IgG	2015-08-06
OSU ACCESS BIO INCORPORATE	CareStartTM Dengue Combo NS1 & IgM/IgG	2015-08-06
JBF ACCESS BIO INCORPORATE	CareStart G6PD	2012-10-16
FMK ACCESS BIO INCORPORATE	ppslC00001	2011-05-11
NED ACCESS BIO INCORPORATE	CareStart Malaria/Pregnancy Combo (HRP2/pLDH/HCG)	2010-08-16
NED ACCESS BIO INCORPORATE	CareStart Malaria pLDH (Pf/PAN)	2010-08-16
NED ACCESS BIO INCORPORATE	CareStart Malaria pLDH (Pf)	2010-08-16
NED ACCESS BIO INCORPORATE	CareStart Malaria pLDH (PAN)	2010-08-16
NED ACCESS BIO INCORPORATE	CareStart Malaria Screen	2010-08-16
NED ACCESS BIO INCORPORATE	CareStart Malaria HRP2/pLDH (Pf/VOM) Combo	2010-08-16
NED ACCESS BIO INCORPORATE	CareStart Malaria HRP2/pLDH (Pf/Pv) Combo	2010-08-16
NED ACCESS BIO INCORPORATE	CareStart Malaria HRP2/pLDH (Pf/PAN) Combo	2010-08-16
NED ACCESS BIO INCORPORATE	CareStart Malaria HRP2/pLDH (Pf)	2010-08-16
NED ACCESS BIO INCORPORATE	CareStart Malaria HRP2 (Pf)	2010-08-16
PMN K051925 ACCESS BIO INCORPORATE	CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN	2005-11-29
PMN K031048 ACCESS BIO INCORPORATE	CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST	2003-06-16
PMN K031052 ACCESS BIO INCORPORATE	CARESTART HCG ONE-STEP PREGNANCY TEST	2003-06-13