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Asfa® Scanner

FDA UDI

Class I (US FDA UDI)

by MBD CO., Ltd.

Identity

Trade Name
ASFA® SCANNER FDA UDI
Generic Name
Fluorescent immunoassay analyser IVD, point-of-care FDA UDI
Device Name
ASFA SCANNER: A fluorescent scanner for cell analysis used for general cell-based biochemical analysis FDA UDI
Model / Reference
MBD-SC-ST005 FDA UDI
Description
ASFA SCANNER: A fluorescent scanner for cell analysis used for general cell-based biochemical analysis FDA UDI

Identifiers

Primary DI / UDI-DI
08800066300104 FDA UDI
FDA Product Code
KHO FDA UDI
GMDN Term
Fluorescent immunoassay analyser IVD, point-of-care FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2560 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

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Width — 846 Millimeter FDA UDI
Depth — 632 Millimeter FDA UDI
Height — 440 Millimeter FDA UDI

Category: Fluorescent immunoassay analyser IVD, point-of-care

Asfa® Scanner by MBD CO., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fluorescent immunoassay analyser IVD, point-of-care.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
MBD CO., Ltd.

Sources (1)

  • FDA UDI 9f0f9ce0-77f3-498f-b35f-0f4c27462146 36 fields · synced May 30, 2026