PREMIER CAMPY - Premier CAMPY enzyme immunoassay (EIA) is an in - MERIDIAN BIOSCIENCE, INC.

Duns Number:092815364

Device Description: Premier CAMPY enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detect 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.

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More Product Details

Catalog Number

618096

Brand Name

PREMIER CAMPY

Version/Model Number

618096

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LQP

Product Code Name

Campylobacter Spp.

Device Record Status

Public Device Record Key

cc3fba80-f090-4a40-b0f4-e6eec2b19f27

Public Version Date

September 09, 2020

Public Version Number

1

DI Record Publish Date

September 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MERIDIAN BIOSCIENCE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 149
2 A medical device with a moderate to high risk that requires special controls. 46
3 A medical device with high risk that requires premarket approval 1