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Sensititre

FDA UDI

Class II (US FDA UDI)

by Trek Diagnostic Systems, Inc.

Identity

Trade Name
Sensititre FDA UDI
Generic Name
Multiple antibacterial susceptibility testing kit IVD FDA UDI
Model / Reference
MDRGN4F FDA UDI

Identifiers

Primary DI / UDI-DI
05032384569137 FDA UDI
510(k) Number
K231994 FDA UDI
FDA Product Code
JWY FDA UDI
GMDN Term
Multiple antibacterial susceptibility testing kit IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.1640 FDA UDI
Commercial Distribution
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

No

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

Yes

FDA UDI

Category: Multiple antibacterial susceptibility testing kit IVD

Sensititre by Trek Diagnostic Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple antibacterial susceptibility testing kit IVD.

Cleared under the same submission

K231994 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Trek Diagnostic Systems, Inc.

Sources (1)

  • FDA UDI f35561d3-dfdb-47b2-950d-65d34e59905e 34 fields · synced May 30, 2026