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MiniCollect

FDA UDI

Class II (US FDA UDI)

by Greiner Bio-One GmbH

Identity

Trade Name
MiniCollect FDA UDI
Generic Name
Non-evacuated blood collection tube IVD, clot activator FDA UDI
Device Name
MiniCollect® TUBE 0.5 ml Z Serum red cap, with cross cut, Spray-dried FDA UDI
Model / Reference
450471 FDA UDI
Description
MiniCollect® TUBE 0.5 ml Z Serum red cap, with cross cut, Spray-dried FDA UDI

Identifiers

Catalog Number
450471 FDA UDI
Primary DI / UDI-DI
29120017578530 FDA UDI
510(k) Number
K982998 FDA UDI
FDA Product Code
JKA FDA UDI
GMDN Term
Non-evacuated blood collection tube IVD, clot activator 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

No

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

No

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

Category: Non-evacuated blood collection tube IVD, clot activator

MiniCollect by Greiner Bio-One GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-evacuated blood collection tube IVD, clot activator.

Cleared under the same submission

K982998 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Greiner Bio-One GmbH

Sources (1)

  • FDA UDI 369186ed-44ba-43d5-aa42-5a3c4e5ead4c 36 fields · synced Jun 8, 2026