Bulk Analyzer Reagent Pack

FDA UDI

Class II (US FDA UDI)

by Selux Diagnostics, Inc.

Identity

Trade Name: Bulk Analyzer Reagent Pack FDA UDI
Generic Name: Antimicrobial susceptibility analyser IVD FDA UDI
Model / Reference: 01-10019 FDA UDI

Identifiers

Primary DI / UDI-DI: 00850031114005 FDA UDI
510(k) Number: K211748 FDA UDI
K211759 FDA UDI
FDA Product Code: LTW FDA UDI
LTT FDA UDI
LON FDA UDI
GMDN Term: Antimicrobial susceptibility analyser IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.1640 FDA UDI
866.1645 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Antimicrobial susceptibility analyser IVD

Bulk Analyzer Reagent Pack by Selux Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K211748 also covers:

K211759 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Selux Diagnostics, Inc.

Sources (1)

FDA UDI 460e0ed1-51a4-4361-ba34-e905f4000f4b 33 fields · synced Jun 6, 2026