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Alfis-3

FDA UDI

by Boditech Med, Inc.

Identity

Trade Name
ALFIS-3 FDA UDI
Generic Name
Fluorescent immunoassay analyser IVD, laboratory, semi-automated FDA UDI
Device Name
FLUOROMETER FOR CLINICAL USE FDA UDI
Model / Reference
FPRR028 FDA UDI
Description
FLUOROMETER FOR CLINICAL USE FDA UDI

Identifiers

Catalog Number
FPRR028 FDA UDI
Primary DI / UDI-DI
08806133010136 FDA UDI
GMDN Term
Fluorescent immunoassay analyser IVD, laboratory, semi-automated FDA UDI

Classification

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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Fluorescent immunoassay analyser IVD, laboratoryFluorescent immunoassay analyser IVD, laboratory, semi-automated

Alfis-3 by Boditech Med, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fluorescent immunoassay analyser IVD, laboratory, semi-automated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boditech Med, Inc.

Sources (1)

  • FDA UDI d6fb318f-f8ac-4cd9-905e-f3a300bda365 34 fields · synced May 30, 2026