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RealTime

FDA UDI

Class II (US FDA UDI)

by Abbott Molecular

Identity

Trade Name
RealTime FDA UDI
Generic Name
DNA anti-contamination enzyme reagent IVD FDA UDI
Device Name
Uracil-N-Glycosylase (UNG) FDA UDI
Model / Reference
06L87-02 FDA UDI
Description
Uracil-N-Glycosylase (UNG) FDA UDI

Identifiers

Catalog Number
06L87-02 FDA UDI
Primary DI / UDI-DI
00884999037472 FDA UDI
PMA Number
P100017 FDA UDI
P120012 FDA UDI
510(k) Number
K080739 FDA UDI
FDA Product Code
MZP FDA UDI
LSL FDA UDI
OBF FDA UDI
MZF FDA UDI
MKZ FDA UDI
GMDN Term
DNA anti-contamination enzyme reagent IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3170 FDA UDI
866.3390 FDA UDI
866.3956 FDA UDI
866.3120 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: DNA anti-contamination enzyme reagent IVD

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

Similar devices

Also classified as DNA anti-contamination enzyme reagent IVD.

Cleared under the same submission

BP060002 also covers:

P100017 also covers:

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 c2f2c793-125f-4af5-a897-a64e9a2abfc5 37 fields · synced May 30, 2026