FDA.reportPublic FDA data

Vela Operations USA, Inc.

Matched from indexed company URL: Vela Operations USA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30090715643009071564Vela Operations USA, Inc.1N2020-04-252441 South 3850 West Salt Lake City UT US 84120

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
G491CDF20Toxigenic C. difficile Direct Test - 01888-320-7636gb.support@veladx.com
G491CDF21Toxigenic C. difficile Direct Test - 01888-320-7636gb.support@veladx.com
G491CDF2SPD0Toxigenic C. difficile Direct Test - Sample Prep - 00888-320-7636gb.support@veladx.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2242221995188464K170284Great Basin Bordetella Direct TestOZZ2017-03-31
2242221878849241K163571Great Basin Stool Bacterial Pathogens PanelPCI2017-07-12
2242221587195368K152955Great Basin Shiga Toxin Direct TestPCH2016-03-22
2242221837219595K152470Great Basin Staph ID/R Blood Culture PanelPAM2016-03-25
2242221655466299K143312Portrait GBS AssayNJR2015-04-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PCI12017-07-12
OZZ12017-03-31
PAM12016-03-25
PCH12016-03-22
NJR12015-04-21

PMN#

GUDID#