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Bone Marrow Kit

FDA UDI

Class I (US FDA UDI)

by Medical Chemical Corporation

Identity

Trade Name
Bone Marrow Kit FDA UDI
Generic Name
Evacuated blood collection tube IVD, K2EDTA FDA UDI
Device Name
A kit for collection and transport of bone marrow specimens. FDA UDI
Model / Reference
4505K FDA UDI
Description
A kit for collection and transport of bone marrow specimens. FDA UDI

Identifiers

Catalog Number
4505K FDA UDI
Primary DI / UDI-DI
M4454505K1 FDA UDI
FDA Product Code
KDT FDA UDI
JKA FDA UDI
KEW FDA UDI
NNI FDA UDI
GMDN Term
Evacuated blood collection tube IVD, K2EDTA FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.3250 FDA UDI
862.1675 FDA UDI
864.3010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: General specimen microscopy slide IVD, single-useGeneral specimen receptacle transport containerEvacuated blood collection tube IVD, anticoagulantEvacuated blood collection tube IVD, K2EDTA

Bone Marrow Kit by Medical Chemical Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Evacuated blood collection tube IVD, K2EDTA.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medical Chemical Corporation

Sources (1)

  • FDA UDI 2510d9de-f978-48f8-8257-2372afe3ad7d 35 fields · synced Jun 9, 2026