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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 RealTime HCV m2000 System Combined Application CD-ROM FDA UDI
Model / Reference
04N45-004 FDA UDI
Description
Abbott RealTime HCV m2000 System Combined Application CD-ROM FDA UDI

Identifiers

Catalog Number
04N45-004 FDA UDI
Primary DI / UDI-DI
00884999042681 FDA UDI
PMA Number
P100017 FDA UDI
FDA Product Code
MZP FDA UDI
GMDN Term
Laboratory instrument/analyser application software IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3170 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

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

P100017 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 45cc8484-fd04-453e-b353-ac153581cfba 36 fields · synced Jun 8, 2026