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Cyto-Chex BCT

FDA UDI

Class II (US FDA UDI)

by Streck

Identity

Trade Name
Cyto-Chex BCT FDA UDI
Generic Name
Evacuated blood collection tube IVD, K3EDTA FDA UDI
Device Name
A direct-draw blood collection tube for the preservation of whole blood specimens for immunophenotyping by flow cytometry. 2 ml vials. FDA UDI
Model / Reference
213559 FDA UDI
Description
A direct-draw blood collection tube for the preservation of whole blood specimens for immunophenotyping by flow cytometry. 2 ml vials. FDA UDI

Identifiers

Catalog Number
213559 FDA UDI
Primary DI / UDI-DI
10844509000836 FDA UDI
510(k) Number
K080552 FDA UDI
FDA Product Code
GIM FDA UDI
GMDN Term
Evacuated blood collection tube IVD, K3EDTA FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1675 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

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

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 — 2.0 Milliliter FDA UDI

Category: Evacuated blood collection tube IVD, K3EDTA

Cyto-Chex BCT by Streck — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Evacuated blood collection tube IVD, K3EDTA.

Cleared under the same submission

K080552 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Streck

Sources (1)

  • FDA UDI e53346d5-f7dd-4b2f-8525-84fde7b6b7e8 38 fields · synced Jun 8, 2026