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Drew Scientific

FDA UDI

Class I (US FDA UDI)

by Drew Scientific , Ltd.

Identity

Trade Name
Drew Scientific FDA UDI
Generic Name
Full blood count IVD, kit, cell count FDA UDI
Device Name
Differential Lyse (20L) FDA UDI
Model / Reference
RA-9020 FDA UDI
Description
Differential Lyse (20L) FDA UDI

Identifiers

Catalog Number
RA-9020 FDA UDI
Primary DI / UDI-DI
00817274020487 FDA UDI
FDA Product Code
GGK FDA UDI
GMDN Term
Full blood count IVD, kit, cell count FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.8540 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Full blood count IVD, kit, cell count

Drew Scientific by Drew Scientific , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Full blood count IVD, kit, cell count.

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 7eadb589-30bf-48eb-b2a3-72186f189444 36 fields · synced May 30, 2026