Identity
- Trade Name
- xMAP® Sheath Concentrate Pack FDA UDI
- Generic Name
- Multiplex analyser IVD, laboratory FDA UDI
- Device Name
- A concentrated version of xMAP® Sheath Fluid, when diluted is is the delivery medium of the sample to the optics component. FDA UDI
- Model / Reference
- 40-75680 FDA UDI
- Description
- A concentrated version of xMAP® Sheath Fluid, when diluted is is the delivery medium of the sample to the optics component. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840487100103 FDA UDI
- FDA Product Code
- NSU FDA UDI
- GMDN Term
- Multiplex analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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: Multiplex analyser IVD, laboratory
xMAP® Sheath Concentrate Pack by Luminex Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiplex analyser IVD, laboratory.
- MEDTOXScan® Reader — MEDTOX DIAGNOSTICS, INC. · Class I
- LIFECODES Fluoroanalyzer — Immucor GTI Diagnostics, Inc. · Class II
- PROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC. · Class II
- PROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC. · Class II
- PROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC. · Class II
- PROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC. · Class II
- PROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC. · Class II
- PROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC. · Class II
Cleared under the same submission
K073506 also covers:
- LIFECODES Fluoroanalyzer — Immucor GTI Diagnostics, Inc.
- Luminex® 100/200™ Calibration Kit — Luminex Corporation
- Luminex® 100/200™ Performance Verification Kit — Luminex Corporation
- xMAP® Sheath Concentrate PLUS — Luminex Corporation
- xMAP® Sheath Fluid — Luminex Corporation
- xMAP® Sheath Fluid PLUS — Luminex Corporation
K083846 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Luminex Corporation
Sources (1)
- FDA UDI 8835f23d-04c7-454b-b562-9e18c67dacb0 36 fields · synced Jun 9, 2026