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MassTrak™

FDA UDI

Class II (US FDA UDI)

by Waters Technologies Corporation

Identity

Trade Name
MassTrak™ FDA UDI
Generic Name
Tacrolimus therapeutic drug monitoring IVD, control FDA UDI
Device Name
Waters® MassTrak™ Immunosuppressants Kit FDA UDI
Model / Reference
186002891 FDA UDI
Description
Waters® MassTrak™ Immunosuppressants Kit FDA UDI

Identifiers

Catalog Number
186002891 FDA UDI
Primary DI / UDI-DI
00816776020001 FDA UDI
510(k) Number
K063868 FDA UDI
FDA Product Code
MLM FDA UDI
JJX FDA UDI
JIT FDA UDI
GMDN Term
Tacrolimus therapeutic drug monitoring IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1678 FDA UDI
862.1660 FDA UDI
862.1150 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: Tacrolimus therapeutic drug monitoring IVD, calibratorTacrolimus therapeutic drug monitoring IVD, control

MassTrak™ by Waters Technologies Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tacrolimus therapeutic drug monitoring IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Waters Technologies Corporation

Sources (1)

  • FDA UDI 14498904-04ed-463b-854c-d2ce3daa3a69 37 fields · synced May 31, 2026