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GenASIs™ System

FDA UDI

Class II (US FDA UDI)

by Applied Spectral Imaging

Identity

Trade Name
GenASIs™ System FDA UDI
Generic Name
Laboratory analyser operation system software IVD FDA UDI
Model / Reference
GenASIs FDA UDI

Identifiers

Primary DI / UDI-DI
07290016630015 FDA UDI
510(k) Number
K012103 FDA UDI
K050236 FDA UDI
K071398 FDA UDI
K101291 FDA UDI
K110345 FDA UDI
K122554 FDA UDI
K140957 FDA UDI
FDA Product Code
JOY FDA UDI
NOT FDA UDI
NQN FDA UDI
LNJ FDA UDI
NTH FDA UDI
GMDN Term
Laboratory analyser operation system software IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.5260 FDA UDI
864.1860 FDA UDI
866.4700 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

GenASIs™ System by Applied Spectral Imaging — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K012103 also covers:

K050236 also covers:

K071398 also covers:

K101291 also covers:

K110345 also covers:

K122554 also covers:

K140957 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Applied Spectral Imaging

Sources (1)

  • FDA UDI b1693f20-471e-4e7d-9581-5c4800a4d0b9 34 fields · synced May 30, 2026