Device Desk

Private service · Not FDA

FDA device establishment · Blaine, WA

This page shows the yearly renewal for this site, from FDA’s public record.

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Renewal dossierDD-3043196750As of September 30, 2026

KEVA INC.

Registration 3043196750FEI 3043196750Blaine, WA

Owner/operator: Keva Inc.

  • Manufacture Device in the United States for Export Only
  • Manufacture Medical Device

Renewal due by December 31, 2026

Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.

90days left in the window

The 2026 window

  1. Oct 1Window opens91 days left
  2. Nov 3Where you stand58 days left
  3. Dec 1Our pay-by date30 days left
  4. Dec 15Two weeks left16 days left
  5. Dec 23Holiday week8 days left
  6. Dec 29Two days left2 days left
  7. Dec 31Window closes0 days left
an email on that date our pay-by date to December 31
FDA fee, FY2027
$13,785
Our pay-by suggestion
Dec 1
Listed devices
28
Added, last 12 months
28

FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page

The steps, in order

  1. Pay FDA's annual feeYou

    Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.

    FDA: registration and listing payment process

  2. Wait for the payment confirmation numberYou

    FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.

    FDA: registration and listing payment process

  3. Renew the registration in FDA's systemYou

    Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.

    FDA: device registration and listing

  4. Review every listingYou

    In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.

    FDA: device registration and listing

Every listed device 28

CodeDeviceClassRegulationPremarket
GRMSALMONELLA TYPHI/PARA TYPHI ANTIGEN TESTAntisera, All Groups, Salmonella Spp.Added Feb 26, 2026Class 221 CFR 866.3550—
PSZINFLUENZA A AND B TESTDevices Detecting Influenza A, B, And C Virus AntigensAdded Feb 26, 2026Class 221 CFR 866.3328—
DJGFENTANYL TESTEnzyme Immunoassay, OpiatesAdded Mar 2, 2026Class 221 CFR 862.3650—
LCXHuman Chorionic Gonadotropin (HCG) Test KitKit, Test, Pregnancy, Hcg, Over The CounterAdded Mar 23, 2026Class 221 CFR 862.1155—
MJHLegionella Antigen TestLegionella, Spp., ElisaAdded Feb 26, 2026Class 221 CFR 866.3300—
KHEFECAL OCCULT BLOOD TESTReagent, Occult BloodAdded Mar 2, 2026Class 221 CFR 864.6550—
DKESYNTHETIC MARIJUANA TESTReagents, Test, TetrahydrocannabinolAdded Feb 26, 2026Class 221 CFR 862.3870—
POVSPERM OK MALE FERTILITY SPERM TESTSemen Analysis DeviceAdded Feb 26, 2026Class 221 CFR 864.5220—
NFTAMPHETAMINE TESTTest, Amphetamine, Over The CounterAdded Feb 26, 2026Class 221 CFR 862.3100—
NFYCOCAINE TESTTest, Cocaine And Cocaine Metabolites, Over The CounterAdded Feb 26, 2026Class 221 CFR 862.3250—
PTGMETHADONE TESTTest, Methadone, Over The CounterAdded Feb 26, 2026Class 221 CFR 862.3620—
NGGMETHAMPHETAMINE TESTTest, Methamphetamine, Over The CounterAdded Feb 26, 2026Class 221 CFR 862.3610—

and 16 more on your full dossier

What changed

  • Feb 26, 2026Listing added: GRM — SALMONELLA TYPHI/PARA TYPHI ANTIGEN TEST
  • Feb 26, 2026Listing added: PSZ — INFLUENZA A AND B TEST
  • Mar 2, 2026Listing added: DJG — FENTANYL TEST
  • Mar 23, 2026Listing added: LCX — Human Chorionic Gonadotropin (HCG) Test Kit
  • Feb 26, 2026Listing added: MJH — Legionella Antigen Test
  • Mar 2, 2026Listing added: KHE — FECAL OCCULT BLOOD TEST
  • Feb 26, 2026Listing added: DKE — SYNTHETIC MARIJUANA TEST
  • Feb 26, 2026Listing added: POV — SPERM OK MALE FERTILITY SPERM TEST
  • Feb 26, 2026Listing added: NFT — AMPHETAMINE TEST
  • Feb 26, 2026Listing added: NFY — COCAINE TEST
  • Feb 26, 2026Listing added: PTG — METHADONE TEST
  • Feb 26, 2026Listing added: NGG — METHAMPHETAMINE TEST
  • Feb 26, 2026Listing added: NGI — MORPHINE TEST
  • Feb 26, 2026Listing added: NGL — FENTANYL TEST
  • Mar 2, 2026Listing added: DJC — METHYLENEDIOXYMETHAMPHETAMINE TEST
  • Feb 26, 2026Listing added: GQG — RESPIRATORY SYNCYTIAL VIRAL ANTIGEN TEST
  • Feb 26, 2026Listing added: GPW — CHLAMYDIA TRACHOMATIS TEST
  • Feb 26, 2026Listing added: GTY — GROUP A STREPTOCOCCUS TEST
  • Feb 26, 2026Listing added: GSB — MYCOPLASMA PNEUMONIAE TEST
  • Mar 2, 2026Listing added: GOB — ADENOVIRUS ANTIGEN RAPID TEST
  • Mar 2, 2026Listing added: MIU — CHAGAS ANTIBODY TEST
  • Feb 26, 2026Listing added: LYR — HELICOBACTER PYLORI ANTIBODY TEST
  • Mar 2, 2026Listing added: NGA — FOLLICLE-STIMULATING HORMONE TEST
  • Aug 11, 2026Listing added: NGA — HerSure FSH Test
  • Mar 2, 2026Listing added: NGE — LUTEINIZING HORMONE TEST
  • Jun 5, 2026Listing added: NGE — HerSure Ovulation Test
  • Mar 2, 2026Listing added: LCM — KETAMINE TEST
  • Feb 26, 2026Listing added: NGM — PHENCYCLIDINE TEST
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov). FDA does not endorse Device Desk.FDA’s own record is always the authority.

How we got this date

  1. FDA asks every device site to renew its registration each year.
  2. The renewal window runs from October 1, 2026 to December 31, 2026.
  3. A renewal in this window covers 2027.
  4. The rule is 21 CFR 807.22(b).

FDA’s record shows this registration runs through 2026.

We read this from FDA’s public record on September 30, 2026.

Read FDA’s page on registration

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Keep this desk: $249 a year

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