Identity
- Trade Name
- Xpert® EUDAMEDXpert Vaginal/Endocervical Specimen Collection Kit FDA UDI
- Generic Name
- Urogenital specimen collection kit IVD, clinical FDA UDI
- Device Name
- Xpert® Vaginal/Endocervical Specimen Collection Kit EUDAMEDXpert Vaginal/Endocervical Specimen Collection Kit; 50 pack FDA UDI
- Model / Reference
- SWAB/A-50 EUDAMEDFDA UDI
- Description
- Xpert Vaginal/Endocervical Specimen Collection Kit; 50 pack FDA UDI
Identifiers
- Catalog Number
- SWAB/A-50 FDA UDI
- Primary DI / UDI-DI
- 07332940002558 EUDAMEDFDA UDI
- Basic UDI-DI
- 081164701-SWAB/A-3H EUDAMED
- FDA Product Code
- LIO FDA UDI
- EMDN Code
- A1102 SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM EUDAMED
- GMDN Term
- Urogenital specimen collection kit IVD, clinical FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2900 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
Category: General-purpose absorbent tip applicator/swab, single-use
Xpert® by Cepheid — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose absorbent tip applicator/swab, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081164701-SWAB/A-3H | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Cepheid
- EUDAMED SRN
- US-MF-000010979
- Authorised Representative
- Cepheid AB SE-AR-000048904
Sources (2)
- EUDAMED c4eb652e-fcc0-41af-886a-407dbd20aa08 61 fields · synced Jul 26, 2026
- FDA UDI 1b17e25a-ea50-4bce-9f62-8d2d61cb7e42 36 fields · synced May 30, 2026