Vela Operations Usa Inc

FDA Filings

This page includes the latest FDA filings for Vela Operations Usa 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: 3009071564
• FEI Number: 3009071564
• Name: Vela Operations USA, Inc.
• Owner & Operator: Vela Operations Singapore Pte Ltd
• Contact Address: 50 Science Park Road #05-07; Singapore SG-01 Central Singapore 117406 SG
• Official Correspondent:
  • Boon King Teh
  • 65-6672-9013-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2441 South 3850 West ; Salt Lake City, UT 84120 US
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID G491CDF2SPD0 Vela Operations USA Inc.	Toxigenic C. difficile Direct Test - Sample Prep CDF2-SPD	2024-01-26
GUDID G491CDF21 Vela Operations USA Inc.	Toxigenic C. difficile Direct Test 300786	2024-01-26
PMN K152955 | PCH Vela Operations USA, Inc. [Vela Operations Singapore Pte Ltd]	Vela? Shiga Toxin Direct Test	2019-06-05
PMN K152470 | PAM Vela Operations USA, Inc. [Vela Operations Singapore Pte Ltd]	Vela? Staph ID/R Blood Culture Panel	2019-06-05
PMN K170284 | OZZ Vela Operations USA, Inc. [Vela Operations Singapore Pte Ltd]	Great Basin Bordetella Direct Test	2019-01-09
PMN K170284 | OOI Vela Operations USA, Inc. [Vela Operations Singapore Pte Ltd]	Great Basin Bordetella Direct Test	2019-01-09
PMN K163571 | PCI Vela Operations USA, Inc. [Vela Operations Singapore Pte Ltd]	Vela Operations US Stool Bacterial Pathogens Panel (SBPP)	2018-11-14
PMN K163571 | PCH Vela Operations USA, Inc. [Vela Operations Singapore Pte Ltd]	Vela Operations US Stool Bacterial Pathogens Panel (SBPP)	2018-11-14
PMN K143312 | NSU Vela Operations USA, Inc. [Vela Operations Singapore Pte Ltd]	Great Basin Group B Streptococcus (GBS) Assay	2018-11-14
PMN K143312 | NJR Vela Operations USA, Inc. [Vela Operations Singapore Pte Ltd]	Great Basin Group B Streptococcus (GBS) Assay	2018-11-14

Related Finance Registrations

DUNS

117416922

Vela Operations Usa Inc.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020090133662	Singapore,Singapore -> Los Angeles, California	BOX AND INNER TRAY HS CODE: 48192000 INCOTERMS: DDP FREIGHT PREPAID ORIGINAL B L SURRENDERED CFS CFS	3 PKG
2020083135296	Singapore,Singapore -> Los Angeles, California	BOX AND INNER TRAY HS CODE: 48192000 INCOTERMS: DDP FREIGHT PREPAID ORIGINAL B L SURRENDERED CFS CFS	3 PKG
2020072362792	Yantian,China (Mainland) -> Long Beach, California	EPE FOAM TRAY CORRUGATED BOX THIS SHIPMENT CONTAINS NO SOLID WOODEN PACKING MATERIALS.	39 CTN
2020020337038	Singapore,Singapore -> New York/Newark Area, Newark, New Jersey	SENTOSA SQ REPORTER	7 CTN
2020020337038	Singapore,Singapore -> New York/Newark Area, Newark, New Jersey	SENTOSA SQ301 SERVER	7 CTN