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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
Prothrombin time (PT) IVD, kit, rapid clotting, clinical FDA UDI
Model / Reference
100362 FDA UDI

Identifiers

Primary DI / UDI-DI
00845275000801 FDA UDI
510(k) Number
K940082 FDA UDI
FDA Product Code
GJS FDA UDI
GMDN Term
Prothrombin time (PT) IVD, kit, rapid clotting, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7750 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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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: Prothrombin time (PT) IVD, kit, rapid clotting, clinical

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

Similar devices

Also classified as Prothrombin time (PT) IVD, kit, rapid clotting, clinical.

Cleared under the same submission

K940082 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fisher Diagnostics

Sources (1)

  • FDA UDI 7c72d491-128e-4795-aec3-3ca377882bdf 35 fields · synced Jun 7, 2026