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Drew

FDA UDI

Class II (US FDA UDI)

by Drew Scientific , Ltd.

Identity

Trade Name
Drew FDA UDI
Generic Name
Prothrombin time (PT) IVD, kit, rapid clotting, clinical FDA UDI
Device Name
DS360 - HbA1c Control (3x 0.5mL L1, 3x 0.5mL L2, 1x 4mL Diluent, 1x 100mL Hemolyzer) FDA UDI
Model / Reference
014-176 FDA UDI
Description
DS360 - HbA1c Control (3x 0.5mL L1, 3x 0.5mL L2, 1x 4mL Diluent, 1x 100mL Hemolyzer) FDA UDI

Identifiers

Primary DI / UDI-DI
00817274020166 FDA UDI
FDA Product Code
JPK FDA UDI
GMDN Term
Prothrombin time (PT) IVD, kit, rapid clotting, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.8625 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

No

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

Drew by Drew Scientific , Ltd. — 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Drew Scientific , Ltd.

Sources (1)

  • FDA UDI 959ea659-683e-4d9a-9edb-7239c539c216 35 fields · synced Jun 1, 2026