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VIDAS® D-Dimer Exclusion II ™

FDA UDI

Class II (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name
VIDAS® D-Dimer Exclusion II ™ FDA UDI
Generic Name
D-dimer IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
VIDAS ® D-Dimer Exclusion II™ is an automated quantitative test for use on the VIDAS instruments indicated for use in conjunction with a clinical model to exclude DVT and PE. FDA UDI
Model / Reference
30455-01 FDA UDI
Description
VIDAS ® D-Dimer Exclusion II™ is an automated quantitative test for use on the VIDAS instruments indicated for use in conjunction with a clinical model to exclude DVT and PE. FDA UDI

Identifiers

Primary DI / UDI-DI
03573026387006 FDA UDI
510(k) Number
K141133 FDA UDI
FDA Product Code
DAP FDA UDI
GMDN Term
D-dimer IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7320 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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: D-dimer IVD, kit, enzyme immunoassay (EIA)

VIDAS® D-Dimer Exclusion II ™ by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as D-dimer IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K141133 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomerieux , Inc.

Sources (1)

  • FDA UDI 259afd9d-f72e-4c22-a54c-f52048d03d51 35 fields · synced Jun 8, 2026