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Opiates Urine Kit

FDA UDI

Class I (US FDA UDI)

by Utak Laboratories, Inc.

Identity

Trade Name
OPIATES URINE KIT FDA UDI
Generic Name
Multiple-therapy therapeutic drug monitoring IVD, control FDA UDI
Device Name
OPIATES URINE KIT FDA UDI
Model / Reference
POS-M245U-4-4 FDA UDI
Description
OPIATES URINE KIT FDA UDI

Identifiers

Catalog Number
POS-M245U-4-4 FDA UDI
Primary DI / UDI-DI
B800POSM245U445 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

Yes

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 — 2 Milliliter FDA UDI

Category: Multiple-therapy therapeutic drug monitoring IVD, control

Opiates Urine Kit 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

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Manufacturer

Manufacturer
Utak Laboratories, Inc.

Sources (1)

  • FDA UDI 2ff451b9-a5ef-4435-b2dd-b4a504c3b2a5 37 fields · synced Jun 8, 2026