Drew Scientific

FDA UDI

Class II (US FDA UDI)

by Drew Scientific , Ltd.

Identity

Trade Name: Drew Scientific FDA UDI
Generic Name: Multiple human hormone IVD, calibrator FDA UDI
Device Name: DS360 HbA1c Calibrator (2x 0.5 mL L1, 2x 0.5mL L2, 1x 4mL Dil, 1x 25mL Hemolyzer) FDA UDI
Model / Reference: 014-385 FDA UDI
Description: DS360 HbA1c Calibrator (2x 0.5 mL L1, 2x 0.5mL L2, 1x 4mL Dil, 1x 25mL Hemolyzer) FDA UDI

Identifiers

Primary DI / UDI-DI: 00817274020227 FDA UDI
FDA Product Code: JIT FDA UDI
GMDN Term: Multiple human hormone IVD, calibrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1150 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

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

FDA UDI

Category: Multiple human hormone IVD, calibrator

Drew Scientific by Drew Scientific , Ltd. — 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: Drew Scientific , Ltd.

Sources (1)

FDA UDI 4624f13f-ec08-472b-bb7e-0828a595fdf0 35 fields · synced May 30, 2026