D-Di Test®

FDA UDI

Class II (US FDA UDI)

by Diagnostica Stago, Inc.

Identity

Trade Name: D-Di Test® FDA UDI
Generic Name: D-dimer IVD, kit, agglutination FDA UDI
Model / Reference: 00454 FDA UDI

Identifiers

Primary DI / UDI-DI: 03607450004540 FDA UDI
510(k) Number: K890399 FDA UDI
FDA Product Code: GHH FDA UDI
GMDN Term: D-dimer IVD, kit, agglutination 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: D-dimer IVD, kit, agglutination

D-Di Test® by Diagnostica Stago, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Diagnostica Stago, Inc.

Sources (1)

FDA UDI 865fa80d-738e-44e3-aa31-a29f1d0d54b3 34 fields · synced May 30, 2026