High Technology Inc

FDA Filings

This page includes the latest FDA filings for High Technology Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3013660430
• FEI Number: 3013660430
• Name: High Technology, Inc.
• Owner & Operator: High Technology, Inc.
• Contact Address: 20 Alice Agnew Dr. ; Attleboro Falls MA 02763 US
• Official Correspondent:
  • Gary Titov
  • x-508-6602221-208
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 20 Alice Agnew Dr ; North Attleboro, MA 02763 US
• Establishment Type:
  • Repack or Relabel Medical Device
  • Manufacture Medical Device
  • Reprocess Single-Use Device
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
GKL High Technology, Inc.	MicroCC-25 Plus	2020-03-02
GKL High Technology, Inc.	MicroCC-20 Vet	2020-03-02
GKL High Technology, Inc.	MicroCC-20 Plus	2020-03-02
GIE High Technology, Inc.	TS4000 Plus	2020-02-25
JJP High Technology, Inc.	Electrode, pH	2019-02-20
JJP High Technology, Inc.	Electrode, Sodium (Na)	2019-02-20
JJP High Technology, Inc.	Electrode, Reference	2019-02-20
JJP High Technology, Inc.	Electrode, Potassium (K)	2019-02-20
JJP High Technology, Inc.	Electrode, Magnesium (Mg)	2019-02-20
JJP High Technology, Inc.	Electrode, Lithium (Li)	2019-02-20
JJP High Technology, Inc.	Electrode, Chloride (Cl)	2019-02-20
JJP High Technology, Inc.	Electrode, Calcium (Ca)	2019-02-20
JJP High Technology, Inc.	Electrode, Blank	2019-02-20
NGE High Technology, Inc.	Luteinizing Hormone, Strip	2017-06-22
PMN K060019 | LCX High Technology, Inc.	hCG, Rapid Test	2017-06-12
PMN K060019 | LCX High Technology, Inc.	hCG Serum/Urine Combo, Cassette	2017-06-12
PMN K060019 | JHI High Technology, Inc.	hCG, Rapid Test	2017-06-12
PMN K060019 | JHI High Technology, Inc.	hCG Serum/Urine Combo, Cassette	2017-06-12
JIR High Technology, Inc.	UrineRS H14	2015-04-02
JIR High Technology, Inc.	UrineRS H13	2015-04-02
JIR High Technology, Inc.	UrineRS H11	2015-04-02
JIR High Technology, Inc.	UrineRS H10	2015-04-02
JIR High Technology, Inc.	UrineRS E10	2015-04-02
JIR High Technology, Inc.	UrineRS A10	2015-04-02
JIR High Technology, Inc.	Calibration Strips	2015-04-02
LPS High Technology, Inc.	Homocysteine Reagent Set	2015-03-27
LPS High Technology, Inc.	Homocysteine Control Set	2015-03-27
JPK High Technology, Inc.	Hemoglobin Control Set	2015-03-27
MDT High Technology, Inc.	Trichinella IgG Elisa kit	2014-02-06
LSG High Technology, Inc.	Candida IgM Elisa kit	2014-02-06
LSG High Technology, Inc.	Candida IgG Elisa kit	2014-02-06
LSG High Technology, Inc.	Candida IgA Elisa kit	2014-02-06
PPM High Technology, Inc.	Washing Solution	2013-08-08
PPM High Technology, Inc.	Washing Solution (De-proteinizer)	2013-08-08
PPM High Technology, Inc.	Washing Solution (Cleaning)	2013-08-08
PPM High Technology, Inc.	Washing Solution (Activation)	2013-08-08
PPM High Technology, Inc.	Refill Solution for Reference Electrode	2013-08-08
PPM High Technology, Inc.	Refill Solution for ISE Electrodes	2013-08-08
PPM High Technology, Inc.	Reagent Pack (Calibrant A, Calibrant B)	2013-08-08
PPM High Technology, Inc.	HTI Enzymatic Cleaner	2013-08-08
PPM High Technology, Inc.	HTI Enzymatic Cleaner Drypack	2013-08-08
PPM High Technology, Inc.	HTI Enzymatic Cleaner Concentrate	2013-08-08
PPM High Technology, Inc.	HTI Cleaning Solution	2013-08-08
PPM High Technology, Inc.	Cleaning Solution	2013-08-08
PPM High Technology, Inc.	CO2 Calibration Solution 1	2013-08-08
PPM High Technology, Inc.	CO2 Acidic Washing Solution	2013-08-08
MRR High Technology, Inc.	Low-density lipoprotein (LDL) Reagent Set	2013-08-08
MJM High Technology, Inc.	Gardnerella vaginalis IgM Elisa kit	2013-08-08
MJM High Technology, Inc.	Gardnerella vaginalis IgG Elisa kit	2013-08-08
MJM High Technology, Inc.	Gardnerella vaginalis IgA Elisa kit	2013-08-08
MHI High Technology, Inc.	Giardiasis (Lambliasis) Elisa Kit	2013-08-08
LCP High Technology, Inc.	Hemoglobin A1c Control Set	2013-08-08
LCP High Technology, Inc.	Hemoglobin A1c (HbA1c) Standard Set	2013-08-08
LCP High Technology, Inc.	Hemoglobin A1c (HbA1c) Reagent Set	2013-08-08
LCP High Technology, Inc.	Hemoglobin A1c (HbA1c) Control Set	2013-08-08
LCP High Technology, Inc.	Hemoglobin A1c (HbA1c) Calibrator Set	2013-08-08
LCP High Technology, Inc.	Glycosylated hemoglobin (HbA1c) Reagent Set	2013-08-08
LCP High Technology, Inc.	Glycohemoglobin Reagent Set	2013-08-08
LCP High Technology, Inc.	Glycohemoglobin Control Set	2013-08-08
LCP High Technology, Inc.	Fructosamine Reagent Set	2013-08-08
LBR High Technology, Inc.	High-density lipoprotein (HDL) Reagent Set	2013-08-08
KNK High Technology, Inc.	Uric Acid Reagent Set	2013-08-08
KIP High Technology, Inc.	HTI Sheath Focusing Solution	2013-08-08
KHS High Technology, Inc.	CO2 Reagent Set	2013-08-08
KHP High Technology, Inc.	Lactate Reagent Set	2013-08-08
KHG High Technology, Inc.	Hemoglobin Reagent Set	2013-08-08
JQB High Technology, Inc.	Gamma-glutamyl transferase (GGT) Reagent Set	2013-08-08
JMO High Technology, Inc.	Total Iron-Binding Capacity (TIBC) Reagent Set	2013-08-08
JMO High Technology, Inc.	Iron (semi-auto) Reagent Set	2013-08-08
JMO High Technology, Inc.	Iron (auto) Reagent Set	2013-08-08
JMO High Technology, Inc.	Direct Total Iron-Binding Capacity (TIBC) Reagent Set	2013-08-08
JJX High Technology, Inc.	Precision Test Fluid P150 & P250	2013-08-08
JJX High Technology, Inc.	Fructosamine Control Set	2013-08-08
JIX High Technology, Inc.	Chemistry Multi-Calibrator Set	2013-08-08
JIT High Technology, Inc.	Microalbumin Standard Set	2013-08-08
JIT High Technology, Inc.	Microalbumin Calibrator Set	2013-08-08
JIS High Technology, Inc.	Lipid Control Set	2013-08-08
JIS High Technology, Inc.	Direct HDL/LDL Control Set	2013-08-08
JGJ High Technology, Inc.	Magnesium Reagent Set	2013-08-08
JFY High Technology, Inc.	Creatinine Reagent Set	2013-08-08
JCB High Technology, Inc.	HTI Detergent	2013-08-08
JCB High Technology, Inc.	HTI Detergent Drypack	2013-08-08
GIF High Technology, Inc.	HTI Hematology Diluent	2013-08-08
GIF High Technology, Inc.	HTI Diluent Drypack	2013-08-08
GGK High Technology, Inc.	HTI Lytic Reagent	2013-08-08
DDZ High Technology, Inc.	Microalbumin Reagent Set	2013-08-08
CIC High Technology, Inc.	Calcium Reagent Set	2013-08-08
CIC High Technology, Inc.	Calcium Arsenazo Reagent Set	2013-08-08
CHJ High Technology, Inc.	Chloride Reagent Set	2013-08-08
CHI High Technology, Inc.	Lipase Reagent Set	2013-08-08
CHH High Technology, Inc.	Cholesterol Reagent Set	2013-08-08
CGS High Technology, Inc.	Creatine Kinase-MB Reagent Set	2013-08-08
CGS High Technology, Inc.	Creatine Kinase (CK) Reagent Set	2013-08-08
CGA High Technology, Inc.	Glucose Oxidase Reagent Set	2013-08-08
CFR High Technology, Inc.	Glucose Hexokinase Reagent Set	2013-08-08
CFJ High Technology, Inc.	Lactate dehydrogenase (LDH-L) Reagent Set	2013-08-08
CEO High Technology, Inc.	Phosphorus Reagent Set	2013-08-08
CEK High Technology, Inc.	Total Protein Reagent Set	2013-08-08
CEK High Technology, Inc.	Microprotein Reagent Set	2013-08-08
CEJ High Technology, Inc.	Potassium Reagent Set	2013-08-08
CEI High Technology, Inc.	Sodium (semi-auto) Reagent Set	2013-08-08
CEI High Technology, Inc.	Sodium (auto) Reagent Set	2013-08-08
CDT High Technology, Inc.	Triglycerides Reagent Set	2013-08-08
CDQ High Technology, Inc.	Urea Nitrogen (BUN) Reagent Set	2013-08-08
JJY High Technology, Inc.	Microalbumin Control Set	2013-08-07
JJY High Technology, Inc.	Linearity Control Material	2013-08-07
JJY High Technology, Inc.	HTI Urine Control Kit	2013-08-07
JJY High Technology, Inc.	HTI Control kit	2013-08-07
JJY High Technology, Inc.	Creatine Kinase-MB Control Set	2013-08-07
JJY High Technology, Inc.	Chemistry Control Set	2013-08-07
JJY High Technology, Inc.	Ammonia/Alcohol Control Set	2013-08-07
JIF High Technology, Inc.	Ammonia Reagent Set	2013-08-07
JFH High Technology, Inc.	Acid Phosphatase Reagent Set	2013-08-07
GJS High Technology, Inc.	HT-Coag Thrombin Time Reagent kit	2013-08-07
GIZ High Technology, Inc.	HT-Coag Multicalibrator Reagent kit	2013-08-07
GIZ High Technology, Inc.	HT-Coag Control 3 Reagent kit	2013-08-07
GIZ High Technology, Inc.	HT-Coag Control 2 Reagent kit	2013-08-07
GIZ High Technology, Inc.	HT-Coag Control 1 Reagent kit	2013-08-07
GIZ High Technology, Inc.	HT-Coag Calibration Plasma Reagent kit	2013-08-07
GGW High Technology, Inc.	HT-Coag PT Reagent kit	2013-08-07
GGC High Technology, Inc.	HT-Coag Lupus Reagent kit	2013-08-07
GGC High Technology, Inc.	HT-Coag Lupus Control Reagent kit	2013-08-07
GFO High Technology, Inc.	HT-Coag APTT Reagent kit	2013-08-07
DIC High Technology, Inc.	Alcohol Reagent Set	2013-08-07
DAP High Technology, Inc.	HT-Coag Thrombin Reagent kit (for Fib Assay)	2013-08-07
DAP High Technology, Inc.	HT-Coag Fibrinogen Reference Plasma Reagent kit	2013-08-07
DAP High Technology, Inc.	HT-Coag Fibrinogen Assay kit	2013-08-07
CKA High Technology, Inc.	Alanine Aminotransferase (ALT or SGPT) Reagent Set	2013-08-07
CKA High Technology, Inc.	ALT, Alanine aminotransferase (GPT), Reagent Set	2013-08-07
CJE High Technology, Inc.	Alkaline Phosphatase Reagent Set	2013-08-07
CIX High Technology, Inc.	Albumin Reagent Set	2013-08-07
CIT High Technology, Inc.	AST, Aspartate aminotransferase (GOT), Reagent Set	2013-08-07
CIJ High Technology, Inc.	Amylase Reagent Set	2013-08-07
CIG High Technology, Inc.	Bilirubin Total (semi-auto) Reagent Set	2013-08-07
CIG High Technology, Inc.	Bilirubin Total (auto) Reagent Set	2013-08-07
CIG High Technology, Inc.	Bilirubin Direct (semi-auto) Reagent Set	2013-08-07
CIG High Technology, Inc.	Bilirubin Direct (auto) Reagent Set	2013-08-07
LJZ High Technology, Inc.	Mycoplasma pneumonia IgM Elisa kit	2013-08-06
LJZ High Technology, Inc.	Mycoplasma pneumonia IgG Elisa kit	2013-08-06
LJZ High Technology, Inc.	Mycoplasma pneumonia IgA Elisa kit	2013-08-06
LIQ High Technology, Inc.	Rotavirus Elisa kit	2013-08-06
JLS High Technology, Inc.	Progesterone Elisa kit	2013-08-06
GOA High Technology, Inc.	Adenovirus IgM Elisa kit	2013-08-06
GOA High Technology, Inc.	Adenovirus IgG Elisa kit	2013-08-06
GOA High Technology, Inc.	Adenovirus IgA Elisa kit	2013-08-06
CHP High Technology, Inc.	Estradiol Elisa kit	2013-08-06
CGJ High Technology, Inc.	FSH Elisa kit	2013-08-06
CFT High Technology, Inc.	Prolactin Elisa kit	2013-08-06
CEP High Technology, Inc.	LH Elisa kit	2013-08-06
CDX High Technology, Inc.	T4 Elisa kit	2013-08-06
CDP High Technology, Inc.	T3 Elisa kit	2013-08-06
CDP High Technology, Inc.	Free T3 Elisa kit	2013-08-06
KSO High Technology, Inc.	Power Spin MX	2011-08-12
KSO High Technology, Inc.	Power Spin LX	2011-08-12
KSO High Technology, Inc.	Power Spin FX	2011-08-12
KSO High Technology, Inc.	Power Spin BX	2011-08-12
KSO High Technology, Inc.	HTI PowerSpin VX Centrifuge	2011-08-12
KSO High Technology, Inc.	HTI PowerSpin Series Centrifuge	2011-08-12
KSO High Technology, Inc.	HTI PowerSpin MX Centrifuge	2011-08-12
KSO High Technology, Inc.	HTI PowerSpin LX Centrifuge	2011-08-12
KSO High Technology, Inc.	HTI PowerSpin HX Centrifuge	2011-08-12
KSO High Technology, Inc.	HTI PowerSpin FX Centrifuge	2011-08-12
IBL High Technology, Inc.	HTI IV-Series Microscope	2011-08-12
IBJ High Technology, Inc.	HTI M-Series Microscope	2011-08-12
IBJ High Technology, Inc.	HTI IP-Series Microscope	2011-08-12
IBJ High Technology, Inc.	HTI H-Series Microscope	2011-08-12
IBJ High Technology, Inc.	HTI G-Series Microscope	2011-08-12
GKG High Technology, Inc.	Power Spin C-MH30	2011-08-12
GKG High Technology, Inc.	HTI C-MH30 Micro-Hematocrit Centrifuge	2011-08-12
LXG High Technology, Inc.	HTI SA-18	2011-01-27
KQO High Technology, Inc.	HTI Urine Analyzer	2011-01-27
KQO High Technology, Inc.	HTI CL-500 Urine Analyzer	2011-01-27
KQO High Technology, Inc.	HTI CL-50 Urine Analyzer	2011-01-27
KQO High Technology, Inc.	HTI CL-50 Plus Urine Analyzer	2011-01-27
KQO High Technology, Inc.	CL-500	2011-01-27
KQO High Technology, Inc.	CL-50 Plus	2011-01-27
JTQ High Technology, Inc.	ImmunoChem 2600	2011-01-27
JTQ High Technology, Inc.	ImmunoChem 2200	2011-01-27
JTQ High Technology, Inc.	HTI ImmunoChem-2600	2011-01-27
JTQ High Technology, Inc.	HTI ImmunoChem-2600 Plus	2011-01-27
JTQ High Technology, Inc.	HTI ImmunoChem-2200	2011-01-27
JTQ High Technology, Inc.	HTI ImmunoChem-2200 Plus	2011-01-27
JJQ High Technology, Inc.	Immunochem-2100	2011-01-27
JJQ High Technology, Inc.	HTI ImmunoChem-2100	2011-01-27
JJE High Technology, Inc.	E-Lyte Plus	2011-01-27
JJE High Technology, Inc.	BioChem SA Plus	2011-01-27
JJE High Technology, Inc.	BioChem FC-360	2011-01-27
JJE High Technology, Inc.	BioChem FC-200	2011-01-27
JJE High Technology, Inc.	BioChem FC-120	2011-01-27

Related Finance Registrations

NCAGE Code	4AS71	HIGH TECHNOLOGY INC.
CAGE Code	4AS71	HIGH TECHNOLOGY, INC.
DUNS	014611607	HIGH TECHNOLOGY, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020021713000	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	CHEMISTY ANALYZER	1 PKG
2020012721386	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	HEMATOLOGY ANALYZER	25 PKG
2020012320563	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	TS4000 COAGULATION ANALYZER THIS SHIPMENT CO NTAINS NO SOLID WOOD PACKING MATERIALS	10 CTN
2020011311333	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	URINE REAGENT	170 PKG
2020010910378	Yantian,China (Mainland) -> Boston, Massachusetts	CUVETTES	551 CTN
202001017466	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	BAR CODE SCANNER	7 PKG
201912192854	Yantian,China (Mainland) -> Boston, Massachusetts	1L SQUARE BOTTLE	190 CTN
2019112118562	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	DODECYL TRIMETHYL AMMONIUM CHLORIDE 99% CLASS : 9 UN NO.: 3077 PG: III 5-BROMO-5-NITRO-1,3- DIOXANE 99% CLASS: 8 UN NO.: 3261 PG: III PRO CAINE HCL 99% CLASS: 6.1 UN NO.: 2811 PG: III	17 DRM