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Premier Campy

FDA UDI

Class I (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name
PREMIER CAMPY FDA UDI
Generic Name
Campylobacter jejuni antibody IVD, enzyme immunoassay (EIA) FDA UDI
Device Name
Premier CAMPY enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of specific Campylobacter antigens in stool samples from patients with signs and symptoms of gastroenteritis. Premier CAMPY detects C. jejuni and C. coli in human stool that may be either unpreserved or preserved in Cary-Blair-based transport media. Test results are to be used in conjunction with information obtained from the patient’s clinical evaluation and other diagnostic procedures. Premier CAMPY is not intended for point-of-care use. The device is intended for use in hospital, reference, regional, private or state laboratory settings. FDA UDI
Model / Reference
618096 FDA UDI
Description
Premier CAMPY enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of specific Campylobacter antigens in stool samples from patients with signs and symptoms of gastroenteritis. Premier CAMPY detects C. jejuni and C. coli in human stool that may be either unpreserved or preserved in Cary-Blair-based transport media. Test results are to be used in conjunction with information obtained from the patient’s clinical evaluation and other diagnostic procedures. Premier CAMPY is not intended for point-of-care use. The device is intended for use in hospital, reference, regional, private or state laboratory settings. FDA UDI

Identifiers

Catalog Number
618096 FDA UDI
Primary DI / UDI-DI
00840733101717 FDA UDI
FDA Product Code
LQP FDA UDI
GMDN Term
Campylobacter jejuni antibody IVD, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3110 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

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: Campylobacter jejuni antibody IVD, enzyme immunoassay (EIA)

Premier Campy by Meridian Bioscience, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Campylobacter jejuni antibody IVD, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Meridian Bioscience, Inc.

Sources (1)

  • FDA UDI cc3fba80-f090-4a40-b0f4-e6eec2b19f27 36 fields · synced May 30, 2026