Jas Diagnostics Drew Scientific

FDA Filings

This page includes the latest FDA filings for Jas Diagnostics Drew Scientific. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Jas Diagnostics Drew Scientific holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• TRANSASIA BIO-MEDICALS LIMITED

FDA Registration(s)

• Registration Number: 1064608
• FEI Number: 3003071743
• Name: JAS Diagnostics/Drew Scientific
• Owner & Operator: JAS Diagnostics/Drew Scientific
• Contact Address: 14100 N.W. 57th Court --; Miami Lakes FL 33014 US
• Official Correspondent:
  • Vivian Roman
  • x-305-3242300-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 14100 N.W. 57th Court ; Miami Lakes, FL 33014 US
• Establishment Type:
  • Repack or Relabel Medical Device
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Device in the United States for Export Only
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K003991 | LIT JAS Diagnostics/Drew Scientific	EX-CAL Hematology Calibrator	2019-01-15
PMN K130915 | JJE JAS Diagnostics/Drew Scientific	XL-200/XL-400	2018-03-02
PMN K130915 | JGS JAS Diagnostics/Drew Scientific	XL-200/XL-400	2018-03-02
PMN K130915 | CGZ JAS Diagnostics/Drew Scientific	XL-200/XL-400	2018-03-02
PMN K130915 | CFR JAS Diagnostics/Drew Scientific	XL-200/XL-400	2018-03-02
PMN K130915 | CEM JAS Diagnostics/Drew Scientific	XL-200/XL-400	2018-03-02
PMN K853592 | JGJ JAS Diagnostics/Drew Scientific	Magnesium Liquid Standard	2017-02-17
PMN K952720 | JPK JAS Diagnostics/Drew Scientific	DS5 HbA1c 2-Level Control Kit	2016-08-26
PMN K952720 | JPK JAS Diagnostics/Drew Scientific	DS360 HbA1c 2-Level Control Kit	2016-08-26
PMN K043378 | JIT JAS Diagnostics/Drew Scientific	DS5 HbA1c 2-Level Calibrator	2016-08-26
PMN K043378 | JIT JAS Diagnostics/Drew Scientific	DS360 HbA1c2-Level Calibrator	2016-08-26
PMN K991539 | GKZ JAS Diagnostics/Drew Scientific	Excell 2280 Hematology Analyzer	2016-08-25
GKZ JAS Diagnostics/Drew Scientific	DS360 Hematology Analyzer	2016-08-25
PMN K954074 | JJY JAS Diagnostics/Drew Scientific	CK-MB Control Level 2	2016-08-10
PMN K954074 | JJY JAS Diagnostics/Drew Scientific	CK-MB Control Level 1	2016-08-10
PMN K942958 | JHW JAS Diagnostics/Drew Scientific	CK-MB Isoenzyme Reagent	2016-08-10
PMN K021671 | LBS JAS Diagnostics/Drew Scientific	Lipid Control	2016-08-10
PMN K021671 | LBS JAS Diagnostics/Drew Scientific	Lipid Calibrator	2016-08-10
PMN K021671 | LBS JAS Diagnostics/Drew Scientific	HDL Cholesterol Reagent Kit	2016-08-10
PMN K021671 | JJY JAS Diagnostics/Drew Scientific	Lipid Control	2016-08-10
PMN K021671 | JJY JAS Diagnostics/Drew Scientific	Lipid Calibrator	2016-08-10
PMN K021671 | JJY JAS Diagnostics/Drew Scientific	HDL Cholesterol Reagent Kit	2016-08-10
PMN K021671 | JIX JAS Diagnostics/Drew Scientific	Lipid Control	2016-08-10
PMN K021671 | JIX JAS Diagnostics/Drew Scientific	Lipid Calibrator	2016-08-10
PMN K021671 | JIX JAS Diagnostics/Drew Scientific	HDL Cholesterol Reagent Kit	2016-08-10
PMN K902616 | JJY JAS Diagnostics/Drew Scientific	Bilirubin Calibrator	2016-08-09
PMN K822469 | CIC JAS Diagnostics/Drew Scientific	Calcium CPC Reagent	2016-08-09
PMN K812341 | CDQ JAS Diagnostics/Drew Scientific	BUN (Urea Nitrogen) Standard	2016-08-09
PMN K070757 | JIX JAS Diagnostics/Drew Scientific	Microprotein Reagent	2016-08-09
PMN K070757 | JGP JAS Diagnostics/Drew Scientific	Microprotein Reagent	2016-08-09
PMN K061511 | JPK JAS Diagnostics/Drew Scientific	EX-Trol Controls (Low, Normal, High)	2016-08-09
PMN K003991 | KSA JAS Diagnostics/Drew Scientific	EX-CAL Hematology Calibrator	2016-08-09
PMN K003991 | KRZ JAS Diagnostics/Drew Scientific	EX-CAL Hematology Calibrator	2016-08-09
PMN K003991 | KRY JAS Diagnostics/Drew Scientific	EX-CAL Hematology Calibrator	2016-08-09
PMN K003991 | KRX JAS Diagnostics/Drew Scientific	EX-CAL Hematology Calibrator	2016-08-09
PMN K003874 | JPK JAS Diagnostics/Drew Scientific	EX-Trol Plus Controls (Low, Normal, High)	2016-08-09
PPM JAS Diagnostics/Drew Scientific	EX-FLO Sheath	2016-08-09
LCP JAS Diagnostics/Drew Scientific	HbGold HPLC Column Kit	2016-08-09
LCP JAS Diagnostics/Drew Scientific	HbGold A1c Reagent Kit	2016-08-09
LCP JAS Diagnostics/Drew Scientific	DS360 Reagent Test Kit	2016-08-09
LCP JAS Diagnostics/Drew Scientific	DS360 HPLC Column	2016-08-09
JCB JAS Diagnostics/Drew Scientific	E-Z Clean, EX-Ezyme, Drew Hematology Clean	2016-08-09
JCB JAS Diagnostics/Drew Scientific	Drew-3 Enzymatic Cleaner	2016-08-09
GIF JAS Diagnostics/Drew Scientific	EX-ISO Hematology Diluent	2013-01-31
GIF JAS Diagnostics/Drew Scientific	Drew-3 Hematology Diluent	2013-01-31
GGK JAS Diagnostics/Drew Scientific	Licon Hemathree Reagent Pack	2013-01-31
GGK JAS Diagnostics/Drew Scientific	EX-PAC2	2013-01-31
GGK JAS Diagnostics/Drew Scientific	EX-Lyse	2013-01-31
GGK JAS Diagnostics/Drew Scientific	Drew-3 Lytic Reagent	2013-01-31
GGK JAS Diagnostics/Drew Scientific	Drew 3 Reagent Pac	2013-01-31
GGK JAS Diagnostics/Drew Scientific	Differential Lyse (20L)	2013-01-31
CKD JAS Diagnostics/Drew Scientific	SGPT Reagent Set	2013-01-31
CHD JAS Diagnostics/Drew Scientific	Cholesterol Reagent Set	2013-01-31
PMN K933287 | LCP JAS Diagnostics/Drew Scientific	DS 5	2013-01-18
PMN K071562 | GKZ JAS Diagnostics/Drew Scientific	Licon Hemat 18	2013-01-18
PMN K071562 | GKZ JAS Diagnostics/Drew Scientific	D3 Hematology Analyzer Model D3	2013-01-18
PMN K070704 | JJE JAS Diagnostics/Drew Scientific	Trilogy Analyzer	2013-01-18
PMN K070704 | JGS JAS Diagnostics/Drew Scientific	Trilogy Analyzer	2013-01-18
PMN K070704 | CGZ JAS Diagnostics/Drew Scientific	Trilogy Analyzer	2013-01-18
PMN K070704 | CGX JAS Diagnostics/Drew Scientific	Trilogy Analyzer	2013-01-18
PMN K070704 | CGA JAS Diagnostics/Drew Scientific	Trilogy Analyzer	2013-01-18
PMN K070704 | CEM JAS Diagnostics/Drew Scientific	Trilogy Analyzer	2013-01-18
PMN K070704 | CDQ JAS Diagnostics/Drew Scientific	Trilogy Analyzer	2013-01-18
PMN K080468 | JJE JAS Diagnostics/Drew Scientific	XL-400	2009-01-26
PMN K080468 | JGS JAS Diagnostics/Drew Scientific	XL-400	2009-01-26
PMN K080468 | CIT JAS Diagnostics/Drew Scientific	XL-400	2009-01-26
PMN K080468 | CGZ JAS Diagnostics/Drew Scientific	XL-400	2009-01-26
PMN K080468 | CGX JAS Diagnostics/Drew Scientific	XL-400	2009-01-26
PMN K080468 | CFR JAS Diagnostics/Drew Scientific	XL-400	2009-01-26
PMN K080468 | CEM JAS Diagnostics/Drew Scientific	XL-400	2009-01-26
PMN K080468 | CDN JAS Diagnostics/Drew Scientific	XL-400	2009-01-26
PMN K991409 | DHR JAS Diagnostics/Drew Scientific	RHEUMATOID FACTOR	2007-12-07
PMN K981339 | JJY JAS Diagnostics/Drew Scientific	Chemistry Controls	2007-12-07
PMN K970781 | CGA JAS Diagnostics/Drew Scientific	Glucose Standard	2007-12-07
PMN K970781 | CGA JAS Diagnostics/Drew Scientific	Glucose Oxidase Reagent	2007-12-07
PMN K970781 | CGA JAS Diagnostics/Drew Scientific	Glucose Ox	2007-12-07
PMN K864882 | JIY JAS Diagnostics/Drew Scientific	IRON/UIBC	2007-12-07
PMN K863832 | JFH JAS Diagnostics/Drew Scientific	ACID PHOS	2007-12-07
PMN K852169 | CHJ JAS Diagnostics/Drew Scientific	Chloride	2007-12-07
PMN K813496 | CFJ JAS Diagnostics/Drew Scientific	LDH	2007-12-07
PMN K031539 | LCP JAS Diagnostics/Drew Scientific	A1C	2007-12-07
PMN K020454 | JIT JAS Diagnostics/Drew Scientific	Chemistry Calibrator Multi	2007-12-07
PMN K020282 | JFJ JAS Diagnostics/Drew Scientific	AMYLASE	2007-12-07
PMN K013912 | CGS JAS Diagnostics/Drew Scientific	CPK	2007-12-07
PMN K013698 | CIT JAS Diagnostics/Drew Scientific	AST SGOT	2007-12-07
PMN K012332 | KHS JAS Diagnostics/Drew Scientific	CARBON DIOXIDE	2007-12-07
PMN K012038 | KNK JAS Diagnostics/Drew Scientific	Uric Acid	2007-12-07
PMN K011900 | CFR JAS Diagnostics/Drew Scientific	Glucose	2007-12-07
PMN K011599 | CJE JAS Diagnostics/Drew Scientific	ALK PHOS	2007-12-07
PMN K011596 | CDQ JAS Diagnostics/Drew Scientific	BUN	2007-12-07
PMN K011441 | CJY JAS Diagnostics/Drew Scientific	Calcium	2007-12-07
PMN K003912 | CEO JAS Diagnostics/Drew Scientific	Phosphorus	2007-12-07
PMN K003835 | JGJ JAS Diagnostics/Drew Scientific	Magnesium	2007-12-07
PMN K003829 | CIG JAS Diagnostics/Drew Scientific	TOTAL BILIRUBIN	2007-12-07
PMN K003693 | CIG JAS Diagnostics/Drew Scientific	DIRECT BILIRUBIN	2007-12-07
PMN K003247 | CGX JAS Diagnostics/Drew Scientific	Creatinine	2007-12-07
PMN K002651 | JIS JAS Diagnostics/Drew Scientific	CRP HS	2007-12-07
PMN K002651 | DCK JAS Diagnostics/Drew Scientific	CRP HS	2007-12-07
PMN K993590 | LCP JAS Diagnostics/Drew Scientific	Fructosamine	2007-10-19
PMN K993590 | JJX JAS Diagnostics/Drew Scientific	Fructosamine	2007-10-19
PMN K972004 | JGS JAS Diagnostics/Drew Scientific	ISE: Buffer, Reference, Cleaning So	2007-10-19
PMN K972004 | CGZ JAS Diagnostics/Drew Scientific	ISE: Buffer, Reference, Cleaning So	2007-10-19
PMN K972004 | CEM JAS Diagnostics/Drew Scientific	ISE: Buffer, Reference, Cleaning So	2007-10-19
PMN K822471 | CIX JAS Diagnostics/Drew Scientific	Albumin Standard	2007-10-19
PMN K020129 | JIX JAS Diagnostics/Drew Scientific	ISE Reference	2007-10-19
PMN K051646 | JGS JAS Diagnostics/Drew Scientific	SODIUM	2006-05-09
PMN K051646 | JGS JAS Diagnostics/Drew Scientific	POTASSIUM	2006-05-09
PMN K051646 | JGS JAS Diagnostics/Drew Scientific	ION SPECIFIC	2006-05-09
PMN K051646 | CGZ JAS Diagnostics/Drew Scientific	SODIUM	2006-05-09
PMN K051646 | CGZ JAS Diagnostics/Drew Scientific	POTASSIUM	2006-05-09
PMN K051646 | CGZ JAS Diagnostics/Drew Scientific	ION SPECIFIC	2006-05-09
PMN K051646 | CEM JAS Diagnostics/Drew Scientific	SODIUM	2006-05-09
PMN K051646 | CEM JAS Diagnostics/Drew Scientific	POTASSIUM	2006-05-09
PMN K051646 | CEM JAS Diagnostics/Drew Scientific	ION SPECIFIC	2006-05-09
PMN K042448 | LPS JAS Diagnostics/Drew Scientific	HOMOCYSTEINE ENZIMATIC ASSAY KIT	2005-09-08
PMN K042448 | JJX JAS Diagnostics/Drew Scientific	HOMOCYSTEINE ENZIMATIC ASSAY KIT	2005-09-08
PMN K882117 | DNN JAS Diagnostics/Drew Scientific	ETHYL ALCOHOL STANDARD	2005-08-22
LBS JAS Diagnostics/Drew Scientific	HDL CHOLESTEROL REAGENT	2004-06-11
LBR JAS Diagnostics/Drew Scientific	HDL CHOLESTEROL	2004-06-11
JZJ JAS Diagnostics/Drew Scientific	PREALBUMIN	2004-06-11
JIQ JAS Diagnostics/Drew Scientific	K-ASSAY MICROALBUMIN	2004-06-11
GTQ JAS Diagnostics/Drew Scientific	STREPTOLYSIN O REAGENT MICROBIOLOGY	2003-11-04
GTQ JAS Diagnostics/Drew Scientific	ANTISTREPTOLYSIN - TITER	2003-11-04
CHI JAS Diagnostics/Drew Scientific	LIPASE	2003-09-02
JQB JAS Diagnostics/Drew Scientific	GAMMA-GT (GGT)	2000-07-11
JHM JAS Diagnostics/Drew Scientific	LDL CHOLESTEROL	2000-07-11
JGQ JAS Diagnostics/Drew Scientific	MICROPROTEIN	2000-07-11
CKA JAS Diagnostics/Drew Scientific	ALT (GPT)	2000-07-11
CHH JAS Diagnostics/Drew Scientific	CHOLESTEROL	2000-07-11
CFJ JAS Diagnostics/Drew Scientific	LDH (LACTATE DEHYDROGERASE)	2000-07-11
CEK JAS Diagnostics/Drew Scientific	TOTAL PROTEIN	2000-07-11
CDT JAS Diagnostics/Drew Scientific	TRIGLYCERIDES	2000-07-11