Thermo Scientific Pacific Hemostasis®

FDA UDI

Class II (US FDA UDI)

by Fisher Diagnostics

Identity

Trade Name: Thermo Scientific Pacific Hemostasis® FDA UDI
Generic Name: D-dimer IVD, kit, agglutination FDA UDI
Model / Reference: 100647 FDA UDI

Identifiers

Primary DI / UDI-DI: 00845275000627 FDA UDI
510(k) Number: K781880 FDA UDI
FDA Product Code: GIS FDA UDI
GMDN Term: D-dimer IVD, kit, agglutination FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.7340 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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

FDA UDI

Category: D-dimer IVD, kit, agglutination

Thermo Scientific Pacific Hemostasis® by Fisher Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as D-dimer IVD, kit, agglutination.

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INNOVANCE® D-Dimer — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II

Cleared under the same submission

K781880 also covers:

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: Fisher Diagnostics

Sources (1)

FDA UDI 00e588d2-7503-40d1-958f-cefab2ead3fc 35 fields · synced Jun 8, 2026