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INTROL CF Panel I Control

FDA UDI

Class II (US FDA UDI)

by Mmqci

Identity

Trade Name
INTROL CF Panel I Control FDA UDI
Generic Name
Cystic fibrosis IVD, control FDA UDI
Device Name
This independent CF control is intended for in vitro diagnostic use to monitor the entire testing process of diagnostic assays used in the detection of the CFTR gene mutations and variants. FDA UDI
Model / Reference
v.02 FDA UDI
Description
This independent CF control is intended for in vitro diagnostic use to monitor the entire testing process of diagnostic assays used in the detection of the CFTR gene mutations and variants. FDA UDI

Identifiers

Catalog Number
G106ac FDA UDI
Primary DI / UDI-DI
00852720008015 FDA UDI
510(k) Number
K083171 FDA UDI
FDA Product Code
NZB FDA UDI
GMDN Term
Cystic fibrosis IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5910 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cystic fibrosis IVD, control

INTROL CF Panel I Control by Mmqci — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cystic fibrosis IVD, control.

Cleared under the same submission

K083171 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mmqci

Sources (1)

  • FDA UDI 658d32f2-0d9a-426b-b834-073300a3cd2e 37 fields · synced Jun 8, 2026