← Back to catalogue

5-key Manual Differential Counter

FDA UDI

Class I (US FDA UDI)

by Lw Scientific, Inc.

Identity

Trade Name
5-key Manual Differential Counter FDA UDI
Generic Name
White blood cell differential count recorder IVD, non-powered FDA UDI
Device Name
5 Key Differential Counter, manual FDA UDI
Model / Reference
CTL-GEN5-M777 FDA UDI
Description
5 Key Differential Counter, manual FDA UDI

Identifiers

Catalog Number
CTL-GEN5-M777 FDA UDI
Primary DI / UDI-DI
00664816003541 FDA UDI
FDA Product Code
GLG FDA UDI
GMDN Term
White blood cell differential count recorder IVD, non-powered FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.6160 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

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: White blood cell differential count recorder IVD, non-powered

5-key Manual Differential Counter by Lw Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as White blood cell differential count recorder IVD, non-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Lw Scientific, Inc.

Sources (1)

  • FDA UDI be8ff4d5-32e5-4b0f-8975-fc45460aa9b8 34 fields · synced May 30, 2026