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Fastep COVID-19 IgG/IgM Rapid Test Device

FDA UDI

Class N (US FDA UDI)

by Assure Tech. (hangzhou) Co., Ltd.

Identity

Trade Name
Fastep COVID-19 IgG/IgM Rapid Test Device FDA UDI
Generic Name
SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical FDA UDI
Model / Reference
1.0 FDA UDI

Identifiers

Primary DI / UDI-DI
06952804805029 FDA UDI
FDA Product Code
QKO FDA UDI
GMDN Term
SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Fastep COVID-19 IgG/IgM Rapid Test Device by Assure Tech. (hangzhou) Co., Ltd. — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Assure Tech. (hangzhou) Co., Ltd.

Sources (1)

  • FDA UDI 8d67728e-0416-439a-9093-95b33c4329f3 32 fields · synced Jun 7, 2026