RealTime

FDA UDI

Class II (US FDA UDI)

by Abbott Molecular

Identity

Trade Name: RealTime FDA UDI
Generic Name: HIV1 nucleic acid IVD, control FDA UDI
Device Name: Abbott RealTime HIV-1 Control Kit FDA UDI
Model / Reference: 6L18-80 FDA UDI
Description: Abbott RealTime HIV-1 Control Kit FDA UDI

Identifiers

Catalog Number: 6L18-80 FDA UDI
Primary DI / UDI-DI: 00884999023932 FDA UDI
FDA Product Code: MZF FDA UDI
GMDN Term: HIV1 nucleic acid IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.3956 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: HIV1 nucleic acid IVD, control

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

Similar devices

Also classified as HIV1 nucleic acid IVD, control.

MAS HIV p24 Positive Control — Microgenics Corporation · Class I
Acrometrix BB NAT HIV-1 POS. CTRL — Microgenics Corporation · Class II
Exact Diagnostics — Exact Diagnostics · Class I
Procleix HIV-1/HCV/HBV Quality Control — Grifols Diagnostic Solutions Inc. · Class II
APTIMA® — Hologic, Inc. · Class II
Exact Diagnostics — Exact Diagnostics · Class I
Exact Diagnostics — Exact Diagnostics · Class I
Alinity m — Abbott Molecular · Class II

Cleared under the same submission

BP060002 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Abbott Molecular

Sources (1)

FDA UDI ffc1fbef-e794-46ab-ade5-ed6de9d3fd32 37 fields · synced May 31, 2026