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RealTime

FDA UDI

Class II (US FDA UDI)

by Abbott Molecular

Identity

Trade Name
RealTime FDA UDI
Generic Name
Laboratory instrument/analyser application software IVD FDA UDI
Device Name
Abbott m2000 System Chlamydia trachomatis and Neisseria gonorrhoeae Application CD-ROM, Version 5.0 FDA UDI
Model / Reference
06L98-05 FDA UDI
Description
Abbott m2000 System Chlamydia trachomatis and Neisseria gonorrhoeae Application CD-ROM, Version 5.0 FDA UDI

Identifiers

Catalog Number
06L98-05 FDA UDI
Primary DI / UDI-DI
00884999037113 FDA UDI
510(k) Number
K140354 FDA UDI
FDA Product Code
LSL FDA UDI
LIO FDA UDI
MKZ FDA UDI
GMDN Term
Laboratory instrument/analyser application software IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3390 FDA UDI
866.2900 FDA UDI
866.3120 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Laboratory instrument/analyser application software IVD

RealTime by Abbott Molecular — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laboratory instrument/analyser application software IVD.

Cleared under the same submission

K140354 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Molecular

Sources (1)

  • FDA UDI 0b5dc530-8355-4fe6-9b27-642371f48429 36 fields · synced Jun 1, 2026