Specimen Collection Kit 146345

by Ditek Consulting LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00860013969561 UDI-DI	Date13 Oct 2025Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Specimen Collection Kit
Generic Name: Phlebotomy kit
Model / Reference: 146345

Primary DI / UDI-DI: 00860013969561
FDA Product Code: OIB
GMDN Term: Phlebotomy kit

Device Class: Class I
Regulation Number: 864.3250
GUDID distribution status: In Commercial Distribution

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Properties

Single Use
Premarket Exempt
Lot / Batch Number
Serial Number
Expiration Date
Manufacturing Date

Other properties (8)

Sterile: No
Implantable: No
Contains Latex: No
Prescription Use: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No