FDA.reportPublic FDA data

ABOUND Diagnostics, Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30304132333030413233ABOUND Diagnostics, Inc1Y2026-01-0112396 World Trade Drive, Suite 216, San Diego CA US 92128

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
00840423500394VivaGuard Lancets (33G) - VGL01-2U18889696928lmariano@abounddiagnostics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3255731779687809K250727AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupNFT2025-04-04
3255731316042325K244043AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupNFT2025-02-27
3255731553966543K242540AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test PanelNFT2024-09-27
3255731318689941K241978Shinetell Digital Pregnancy TestLCX2024-08-13
3255731281390607K241428AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test CupNFT2024-06-17
3255731695509583K234152ACESO Early Pregnancy TestLCX2024-04-05
3255731377868308K233417AllTest Fentanyl Urine Test CassetteNGL2023-10-26
3255731365855958K233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxDKZ2023-12-13
3255731455068484K231698AllTest Fentanyl Rapid Test (Urine)DJG2023-07-31
3255731184237005K203272Alltest Pregnancy Rapid Combo Test CassetteJHI2022-01-31
3255731255118161K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)DKZ2019-03-27

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NFT42025-04-04
LCX22024-08-13
DKZ22023-12-13
NGL12023-10-26
DJG12023-07-31
JHI12022-01-31

GUDID#