FDA.reportPublic FDA data

AFFINITY BIOSENSORS

Matched from indexed company URL: Affinity Biosensors

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30257722773025772277AFFINITY BIOSENSORS1N2026-01-01222 E Canon Perdido St Ste 101 Santa Barbara CA US 93101

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
00860012092109LifeScale AST - LifeScale AST is a semi-automated instrument system for antimicrobial susceptibility testing (AST) directly from positive blood cultures for which the Gram stain shows gram-negative bacilli.805-960-5100info@affinitybio.com
00860012092116LSGN - LifeScale Gram Negative Kit (LSGN) is used with the LifeScale AST system for testing positive blood culture samples containing gram-negative bacilli.805-960-5100info@affinitybio.com
00860012092123LifeScale Sensor - The LifeScale Sensor is a consumable that detects organisms in the sample and measures the individual mass of eachcell.805-960-5100info@affinitybio.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3304991891356474K211815LifeScale Gram Negative Kit (LSGN) with the LifeScale AST SystemSAN2024-04-02

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
SAN12024-04-02

PMN#

GUDID#