← Back to catalogue

Fastep

FDA UDI

Class N (US FDA UDI)

by Azure Biotech Inc

Identity

Trade Name
Fastep FDA UDI
Generic Name
SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical FDA UDI
Device Name
Fastep COVID-19 Antigen Home Test 4 Test Per Pack FDA UDI
Model / Reference
COV-S23010H4 FDA UDI
Description
Fastep COVID-19 Antigen Home Test 4 Test Per Pack FDA UDI

Identifiers

Primary DI / UDI-DI
00810022630365 FDA UDI
FDA Product Code
QKP FDA UDI
GMDN Term
SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
N FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

Fastep by Azure Biotech Inc — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Azure Biotech Inc

Sources (1)

  • FDA UDI a5870842-b3f6-4ef1-8c1f-38ed6fdbf968 33 fields · synced May 30, 2026