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MiSeqDx Cystic Fibrosis Clinical Sequencing Assay (6 Run)

FDA UDI

Class II (US FDA UDI)

by Illumina, Inc.

Identity

Trade Name
MiSeqDx Cystic Fibrosis Clinical Sequencing Assay (6 Run) FDA UDI
Generic Name
Cystic fibrosis IVD, kit, multiplex FDA UDI
Device Name
The Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay consists of library preparation and sample indexing reagents, sequencing reagents and consumables, MiSeqDx instrument and data analysis software. MiSeqDx Cystic Fibrosis Clinical Sequencing Assay is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 15035429 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 1/5 15038248 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 1A 15038249 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 1B 15035436 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 2/5 15035430 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 3/5 15038250 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 3A 15038251 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 3B 15036622 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 4/5 15036623 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 5/5 FDA UDI
Model / Reference
15036620 FDA UDI
Description
The Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay consists of library preparation and sample indexing reagents, sequencing reagents and consumables, MiSeqDx instrument and data analysis software. MiSeqDx Cystic Fibrosis Clinical Sequencing Assay is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 15035429 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 1/5 15038248 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 1A 15038249 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 1B 15035436 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 2/5 15035430 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 3/5 15038250 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 3A 15038251 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 3B 15036622 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 4/5 15036623 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 5/5 FDA UDI

Identifiers

Catalog Number
DX-102-1001 FDA UDI
Primary DI / UDI-DI
00816270020026 FDA UDI
510(k) Number
K132750 FDA UDI
FDA Product Code
PFS FDA UDI
GMDN Term
Cystic fibrosis IVD, kit, multiplex FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5900 FDA UDI
Commercial Distribution
Not 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

Yes

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

MiSeqDx Cystic Fibrosis Clinical Sequencing Assay (6 Run) by Illumina, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K132750 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Illumina, Inc.

Sources (1)

  • FDA UDI 0e2913bc-ca16-413e-aefa-e6d935e4dd34 37 fields · synced May 30, 2026