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Biosci™

FDA UDI

Class I (US FDA UDI)

by Shenzhen Dakewe Bio-Engineering Co., Ltd.

Identity

Trade Name
Biosci™ FDA UDI
Generic Name
General tissue specimen container IVD, fixative/saline FDA UDI
Device Name
3 ml of 0.85% Biosci™ Sterile Normal Saline in screw-cap tube, with oropharyngeal swab. FDA UDI
Model / Reference
MSY FDA UDI
Description
3 ml of 0.85% Biosci™ Sterile Normal Saline in screw-cap tube, with oropharyngeal swab. FDA UDI

Identifiers

Primary DI / UDI-DI
06973471960712 FDA UDI
FDA Product Code
QMC FDA UDI
GMDN Term
General tissue specimen container IVD, fixative/saline FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2390 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

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

Yes

FDA UDI

Category: General tissue specimen container IVD, fixative/saline

Biosci™ by Shenzhen Dakewe Bio-Engineering Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General tissue specimen container IVD, fixative/saline.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shenzhen Dakewe Bio-Engineering Co., Ltd.

Sources (1)

  • FDA UDI 5a2370ca-850b-4ae1-9033-68a21cb1ccca 33 fields · synced May 30, 2026