← Back to catalogue

e-CHECK(XE)

FDA UDI

Class II (US FDA UDI)

by Sysmex Corp.

Identity

Trade Name
e-CHECK(XE) FDA UDI
Generic Name
Full blood count IVD, control FDA UDI
Device Name
E-Check (XE) 4X4.5MLX3 Levels FDA UDI
Model / Reference
201-6001-0 FDA UDI
Description
E-Check (XE) 4X4.5MLX3 Levels FDA UDI

Identifiers

Primary DI / UDI-DI
14987562460295 FDA UDI
510(k) Number
K063218 FDA UDI
FDA Product Code
JPK FDA UDI
GMDN Term
Full blood count IVD, control 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

Yes

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

Dimensions & Sizes

Size
Total Volume — 4.5 Milliliter FDA UDI

Category: Full blood count IVD, control

e-CHECK(XE) by Sysmex Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Full blood count IVD, control.

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
Sysmex Corp.

Sources (1)

  • FDA UDI 628f2f1e-6c7a-4e1f-8862-3018cc119548 37 fields · synced May 29, 2026