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simpli-COLLECT

FDA UDI

Class II (US FDA UDI)

by Abbott Molecular

Identity

Trade Name
simpli-COLLECT FDA UDI
Generic Name
General specimen container IVD, no additive/medium FDA UDI
Device Name
simpli-COLLECT Urine Collection Kit FDA UDI
Model / Reference
09N93-001 FDA UDI
Description
simpli-COLLECT Urine Collection Kit FDA UDI

Identifiers

Catalog Number
09N93-001 FDA UDI
Primary DI / UDI-DI
00884999051409 FDA UDI
510(k) Number
K243410 FDA UDI
FDA Product Code
QYA FDA UDI
GMDN Term
General specimen container IVD, no additive/medium FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3385 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 specimen container IVD, no additive/medium

simpli-COLLECT by Abbott Molecular — Class II — 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

K243410 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Molecular

Sources (1)

  • FDA UDI c2184cd9-dbf8-417b-ad67-354af5e5ac19 37 fields · synced May 29, 2026