← Back to catalogue

Ads/Aps Control Solution V3

FDA UDI

Class I (US FDA UDI)

by Utak Laboratories, Inc.

Identity

Trade Name
ADS/APS CONTROL SOLUTION V3 FDA UDI
Generic Name
Multiple-therapy therapeutic drug monitoring IVD, control FDA UDI
Device Name
ADS/APS CONTROL SOLUTION V3 FDA UDI
Model / Reference
ADS/APSV3CONTFCCO FDA UDI
Description
ADS/APS CONTROL SOLUTION V3 FDA UDI

Identifiers

Catalog Number
ADS/APSV3CONTFCCO FDA UDI
Primary DI / UDI-DI
B800ADSAPSV3CONTFCCO0 FDA UDI
FDA Product Code
LAS FDA UDI
GMDN Term
Multiple-therapy therapeutic drug monitoring IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.3280 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

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 — 25 Milliliter FDA UDI

Category: Multiple-therapy therapeutic drug monitoring IVD, control

Ads/Aps Control Solution V3 by Utak Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-therapy therapeutic drug monitoring IVD, control.

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
Utak Laboratories, Inc.

Sources (1)

  • FDA UDI 9737ab59-acd7-4628-991d-f3554ce3d3b6 37 fields · synced May 31, 2026