← Back to catalogue

Multi-Collect

FDA UDI

Class I (US FDA UDI)

by Abbott Molecular

Identity

Trade Name
Multi-Collect FDA UDI
Generic Name
General specimen container IVD, no additive/medium FDA UDI
Device Name
multi-Collect Specimen Collection Specimen Collection Kit FDA UDI
Model / Reference
9K12-03 FDA UDI
Description
multi-Collect Specimen Collection Specimen Collection Kit FDA UDI

Identifiers

Catalog Number
9K12-03 FDA UDI
Primary DI / UDI-DI
00884999046511 FDA UDI
510(k) Number
K140354 FDA UDI
FDA Product Code
MKZ FDA UDI
LIO FDA UDI
LSL FDA UDI
GMDN Term
General specimen container IVD, no additive/medium FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3120 FDA UDI
866.2900 FDA UDI
866.3390 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

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

Category: General-purpose absorbent tip applicator/swab, single-useGeneral specimen container IVD, no additive/medium

Multi-Collect by Abbott Molecular — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General specimen container IVD, no additive/medium.

Cleared under the same submission

K140354 also covers:

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
Abbott Molecular

Sources (1)

  • FDA UDI dfe1cfb7-b38a-4f36-bd3e-e55f23a76c88 37 fields · synced May 30, 2026