Bioarray Solutions L T D

FDA Filings

This page includes the latest FDA filings for Bioarray Solutions L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3005967741
FEI Number3005967741
NameBIOARRAY SOLUTIONS LIMITED
Owner & OperatorBioarray Solutions Limited
Contact Address35 Technology Drive Suite 100
Warren NJ 07059 US
Official Correspondent
  • Luz D Villamizar
  • x-908-4449591-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address35 Technology Dr Ste 100
Warren, NJ 07059 US
Establishment Type
  • Manufacture Device in the United States for Export Only
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
BIOARRAY SOLUTIONS LTD
Carrier Box, ETC, Slide, IVD 800-203012018-07-06
BIOARRAY SOLUTIONS LTD
Precise TypeTM HEA BeadCheck Kit 800-202362018-07-06
BIOARRAY SOLUTIONS LTD
Immucor Precise TypeTM Human Erythrocyte Antigen M 800-20202-962018-07-06
BIOARRAY SOLUTIONS LTD
BeadCheck HEA Ref-pB, Bulk and Fill 800-002292018-07-06
BIOARRAY SOLUTIONS LTD
BeadCheck HEA Ref-pA, Bulk and Fill 800-002282018-07-06
BIOARRAY SOLUTIONS LTD
BioArray Assay Imaging System TM (AIS) 400D 790-20016-RF2018-07-06
BIOARRAY SOLUTIONS LTD
BioArray Assay Imaging System TM (AIS) 400D 790-200162018-07-06
BIOARRAY SOLUTIONS LTD
BioArray Assay Imaging System TM (AIS) 400C 790-20006-RF2018-07-06
BIOARRAY SOLUTIONS LTD
BioArray Assay Imaging SystemTM (AIS) 400C 790-200062018-07-06
BIOARRAY SOLUTIONS LTD
Filled Vial,HotStarTaq DNA Polymerase 800-102422018-07-06
BIOARRAY SOLUTIONS LTD
Filled Vial,Negative Control 1mL 800-002872018-07-06
BIOARRAY SOLUTIONS LTD
Filled Vial, Lambda Exonuclease 800-001952018-07-06
BIOARRAY SOLUTIONS LTD
Filled Vial, HEA 1.2 PCR Mix 800-001942018-07-06
BIOARRAY SOLUTIONS LTD
Filled Vial, eMAPTM Elongation Mix 800-001932018-07-06
BIOARRAY SOLUTIONS LTD
Filled Vial, Clean-up, 330uL 800-001912018-07-06
BIOARRAY SOLUTIONS LTD
Immucor Precise TypeTM Human Erythrocyte Antigen M 800-20202-082018-07-06
BIOARRAY SOLUTIONS LIMITED
Array Imaging System (AIS) 400D2015-07-16
BioArray Solutions, Ltd.
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices 2015-06-15
BIOARRAY SOLUTIONS LIMITED
Immucor PreciseType Human Erythrocyte Antigen Molecular BeadChip Test2014-08-18
BIOARRAY SOLUTIONS LIMITED
BioArray Array Imaging System (AIS) 400C2014-08-18
BIOARRAY SOLUTIONS LIMITED
PreciseType HEA BeadCheck Kit2014-08-18
BioArray Solutions, Ltd.
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices 2014-05-21
BioArray Solutions, Ltd.
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices 2014-05-21
BIOARRAY SOLUTIONS LIMITED
Array Imaging System AIS400C2012-07-30
BIOARRAY SOLUTIONS LIMITED
HPA BeadChip Test Kit2012-07-30
BIOARRAY SOLUTIONS LIMITED
HEA 1.2 BeadChip Test Kit2012-07-30
BIOARRAY SOLUTIONS LTD
ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 4002005-05-31

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