← Back to catalogue

Platelet CHECK

FDA UDI

Class II (US FDA UDI)

by Sysmex Corp.

Identity

Trade Name
Platelet CHECK FDA UDI
Generic Name
Full blood count IVD, control FDA UDI
Device Name
Platelet CHECK Level 2-16x3.0ML FDA UDI
Model / Reference
CC118360 FDA UDI
Description
Platelet CHECK Level 2-16x3.0ML FDA UDI

Identifiers

Catalog Number
Platelet CHECK FDA UDI
Primary DI / UDI-DI
14987562508003 FDA UDI
FDA Product Code
GJP 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 — 3 Milliliter FDA UDI

Category: Full blood count IVD, control

Platelet CHECK 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 70cc1006-de58-47fb-bf95-e10990351555 37 fields · synced May 30, 2026