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Sensititre GP Panel PLATE DRY CLI GRAM+ ID AUTO

FDA UDI

Class I (US FDA UDI)

by Remel, Inc.

Identity

Trade Name
Sensititre GP Panel PLATE DRY CLI GRAM+ ID AUTO FDA UDI
Generic Name
Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit FDA UDI
Device Name
PLATE DRY CLI GRAM+ ID AUTO A semi-quantitative test intended for the automated identification of Gram positive bacterial isolates based on biochemical reactions. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, the device requires an automated system to produce a result and requires a pure, agar grown culture. This device is for professional use only and is not a companion diagnostic. FDA UDI
Model / Reference
GPID FDA UDI
Description
PLATE DRY CLI GRAM+ ID AUTO A semi-quantitative test intended for the automated identification of Gram positive bacterial isolates based on biochemical reactions. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, the device requires an automated system to produce a result and requires a pure, agar grown culture. This device is for professional use only and is not a companion diagnostic. FDA UDI

Identifiers

Primary DI / UDI-DI
00848838074363 FDA UDI
FDA Product Code
LQL FDA UDI
GMDN Term
Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2660 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit

Sensititre GP Panel PLATE DRY CLI GRAM+ ID AUTO by Remel, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Remel, Inc.

Sources (1)

  • FDA UDI 5283b48e-7ec1-443c-b89d-4076081476a6 33 fields · synced May 30, 2026