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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 Genotype II m2000 System Combined Application CD-ROM FDA UDI
Model / Reference
08L21-002 FDA UDI
Description
Abbott RealTime HCV Genotype II m2000 System Combined Application CD-ROM FDA UDI

Identifiers

Catalog Number
08L21-002 FDA UDI
Primary DI / UDI-DI
00884999042513 FDA UDI
PMA Number
P120012 FDA UDI
FDA Product Code
OBF 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

P120012 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 1402afc9-e612-4a02-8495-b9cf7a1b3e49 36 fields · synced May 30, 2026