Xpert®

EUDAMEDFDA 510(k)FDA UDI

Class A (EU MDR)

Ref GXFFPE-LYSIS-CE-10510(k) K151565Ref XPERTCHECK-CE-5Ref GXUTR-CE-30Ref SWAB/B-100Ref GXBCRABL-10Ref GXBCRABLP190-CE-10

by Cepheid

Identity

Trade Name: Xpert® EUDAMED
Xpert Nasopharyngeal Sample Collection Kit FDA UDI
Generic Name: General specimen collection kit IVD, clinical FDA UDI
Device Name: Xpert® FFPE Lysis Kit EUDAMED
Xpert® Check EUDAMED
Xpert® Urine Transport Reagent Kit EUDAMED
Xpert® Nasopharyngeal Sample Collection Kit EUDAMED
Xpert® BCR-ABL Ultra EUDAMED
Xpert® BCR-ABL Ultra p190 EUDAMED
Xpert Nasopharyngeal Sample Collection Kit; 100 pack FDA UDI
Model / Reference: GXFFPE-LYSIS-CE-10 EUDAMED
SWAB/B-100 EUDAMEDFDA UDI
XPERTCHECK-CE-5 EUDAMED
GXUTR-CE-30 EUDAMED
GXBCRABL-10 EUDAMED
GXBCRABLP190-CE-10 EUDAMED
Description: Xpert Nasopharyngeal Sample Collection Kit; 100 pack FDA UDI

Identifiers

Catalog Number: SWAB/B-100 FDA UDI
Primary DI / UDI-DI: 07332940006013 EUDAMED
07332940002565 EUDAMEDFDA UDI
07332940001865 EUDAMED
07332940002305 EUDAMED
07332940001834 EUDAMED
07332940007898 EUDAMED
Basic UDI-DI: 081164701-GXFFPE-LYSIS-MP EUDAMED
081164701-XPERTCHECK-3B EUDAMED
081164701-GXUTR-2L EUDAMED
081164701-SWAB/B-3L EUDAMED
B-07332940001834 EUDAMED
B-07332940007898 EUDAMED
510(k) Number: K151565 FDA 510(k)
FDA Product Code: OUY FDA 510(k)
JSM FDA UDI
EMDN Code: W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
W02050199 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER EUDAMED
W05010299 URINE COLLECTION DEVICES - OTHER EUDAMED
A1102 SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM EUDAMED
W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
GMDN Term: General specimen collection kit IVD, clinical FDA UDI

Classification

Device Class: Class A EUDAMED
Class IVD General EUDAMED
Class II FDA 510(k)
Class I FDA UDI
Legislation / Framework: 21 CFR Part 866.3860 FDA 510(k)
Regulation Number: 866.3860 FDA 510(k)
866.2390 FDA UDI
Market of Registration: Netherlands EUDAMED
Advisory Committee: Immunology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Human Tissues

EUDAMED

Animal Tissues

EUDAMEDEUDAMED

Microbial Substances

Yes

EUDAMEDEUDAMED

Reagent

EUDAMEDEUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

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: Nucleic acid extraction/isolation kit IVD

Xpert® by Cepheid — Class A — IVDD, FDA_510K, IVDR — listed in EUDAMED, FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nucleic acid extraction/isolation kit IVD.

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VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
ViraSens Total Nucleic Acid Purification Kit — Vitrosens Biotechnology Inc. · Class A
Nucleic Acid Extraction Kit — Bioteke Corporation (Wuxi) Co., Ltd. · Class A
MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

United States Active

FDA_510K

European Union Active

CE/IVDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	081164701-GXFFPE-LYSIS-MP	Class A	Active
FDA 510(k)	United States	FDA_510K	K151565	Class A	Active
EUDAMED	European Union	CE/IVDR	081164701-GXFFPE-LYSIS-MP	Class A	Active

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Manufacturer

Manufacturer: Cepheid
EUDAMED SRN: US-MF-000010979
Authorised Representative: Cepheid AB SE-AR-000048904

Sources (8)

EUDAMED 81f036dd-98dc-4f28-8a08-4685ee8cfd3d 61 fields · synced Aug 4, 2026
FDA 510(k) K151565 24 fields · synced May 18, 2026
FDA UDI 944100d9-6cf6-4142-9097-09394e8979f8 36 fields · synced May 30, 2026
EUDAMED 2a245a08-5896-41a9-9e29-3ff8331ad883 61 fields · synced Jul 10, 2026
EUDAMED 3b6c6bd1-07ac-4979-8a77-5aceca44117a 61 fields · synced Jul 14, 2026
EUDAMED fee91a0b-f64e-41c1-b57e-55a65dc713d9 61 fields · synced Jul 16, 2026
EUDAMED f39eb5ea-7b05-4700-9379-d8091cb7eb45 61 fields · synced Aug 4, 2026
EUDAMED 5ea92a28-7230-40ac-bf38-8d466958eb72 61 fields · synced Aug 4, 2026