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Osito

FDA UDI

Class II (US FDA UDI)

by Shenzhen Osto Technology Co., Ltd.

Identity

Trade Name
OSITO FDA UDI
Generic Name
Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control FDA UDI
Model / Reference
AST-905D FDA UDI

Identifiers

Primary DI / UDI-DI
06950940801738 FDA UDI
510(k) Number
K210756 FDA UDI
FDA Product Code
NGX FDA UDI
NUH FDA UDI
GMDN Term
Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5850 FDA UDI
882.5890 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control

Osito by Shenzhen Osto Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control.

Cleared under the same submission

K210756 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shenzhen Osto Technology Co., Ltd.

Sources (1)

  • FDA UDI 97d19a1c-501f-4d99-b276-d77d38090857 33 fields · synced May 30, 2026