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PREMIER Adenoclone Type 40/41

FDA UDI

Class I (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name
PREMIER Adenoclone Type 40/41 FDA UDI
Generic Name
Adenovirus antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Premier Adenoclone-Type 40/41 is an enzyme immunoassay (EIA) for the qualitative detection of enteric adenovirus serotypes 40 and 41 in human fecal specimens. FDA UDI
Model / Reference
696006 FDA UDI
Description
Premier Adenoclone-Type 40/41 is an enzyme immunoassay (EIA) for the qualitative detection of enteric adenovirus serotypes 40 and 41 in human fecal specimens. FDA UDI

Identifiers

Catalog Number
696006 FDA UDI
Primary DI / UDI-DI
00840733101748 FDA UDI
510(k) Number
K881894 FDA UDI
FDA Product Code
GOD FDA UDI
GMDN Term
Adenovirus antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3020 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: Adenovirus antigen IVD, kit, enzyme immunoassay (EIA)

PREMIER Adenoclone Type 40/41 by Meridian Bioscience, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Adenovirus antigen IVD, kit, 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 324d3ee9-4f36-4dbb-828e-af70b29b64da 37 fields · synced May 30, 2026