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Normal Range Trace Elements

FDA UDI

Class I (US FDA UDI)

by Utak Laboratories, Inc.

Identity

Trade Name
Normal Range Trace Elements FDA UDI
Generic Name
Multiple heavy metal IVD, control FDA UDI
Device Name
NR Trace Elements FDA UDI
Model / Reference
66816 FDA UDI
Description
NR Trace Elements FDA UDI

Identifiers

Catalog Number
66816 FDA UDI
Primary DI / UDI-DI
B800668160 FDA UDI
FDA Product Code
JJY FDA UDI
GMDN Term
Multiple heavy metal IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 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 — 5 Milliliter FDA UDI

Category: Multiple heavy metal IVD, control

Normal Range Trace Elements by Utak Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple heavy metal 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 ad2d2d42-6a9b-44ee-b461-71846163b83f 37 fields · synced May 30, 2026