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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
Gram positive bacteria species culture isolate identification/antimicrobial susceptibility profile IVD, kit FDA UDI
Model / Reference
GPN3F FDA UDI

Identifiers

Primary DI / UDI-DI
M578GPN3F2 FDA UDI
510(k) Number
K033522 FDA UDI
FDA Product Code
JWY FDA UDI
GMDN Term
Gram positive bacteria species culture isolate identification/antimicrobial susceptibility profile IVD, kit 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

No

FDA UDI

Category: Gram positive bacteria species culture isolate identification/antimicrobial susceptibility profile IVD, kit

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

Similar devices

Also classified as Gram positive bacteria species culture isolate identification/antimicrobial susceptibility profile IVD, kit.

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 81c11785-2fcf-4316-82af-46ccec3cf54e 34 fields · synced May 29, 2026