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RealTime

FDA UDI

Class I (US FDA UDI)

by Abbott Molecular

Identity

Trade Name
RealTime FDA UDI
Generic Name
DNA anti-contamination enzyme reagent IVD FDA UDI
Device Name
Abbott RealTime CT/NG Amplification Reagent Extended Use Including Uracil-N-Glycosylase (UNG) FDA UDI
Model / Reference
8L07-67 FDA UDI
Description
Abbott RealTime CT/NG Amplification Reagent Extended Use Including Uracil-N-Glycosylase (UNG) FDA UDI

Identifiers

Catalog Number
8L07-67 FDA UDI
Primary DI / UDI-DI
00884999037410 FDA UDI
510(k) Number
K140354 FDA UDI
FDA Product Code
LIO FDA UDI
MKZ FDA UDI
LSL FDA UDI
GMDN Term
DNA anti-contamination enzyme reagent IVD FDA UDI

Classification

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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: DNA anti-contamination enzyme reagent IVD

RealTime by Abbott Molecular — Class I — 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

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 8820dec8-0137-47c5-b2e7-80fb6cca3dce 36 fields · synced May 30, 2026