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DHEA Plus Low

FDA UDI

Class I (US FDA UDI)

by Utak Laboratories, Inc.

Identity

Trade Name
DHEA Plus Low FDA UDI
Generic Name
Multiple steroid hormone IVD, control FDA UDI
Device Name
DHEA Plus Low FDA UDI
Model / Reference
51410 FDA UDI
Description
DHEA Plus Low FDA UDI

Identifiers

Primary DI / UDI-DI
B800514100 FDA UDI
FDA Product Code
LAS FDA UDI
GMDN Term
Multiple steroid hormone 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 — 3 Milliliter FDA UDI

Category: Multiple steroid hormone IVD, control

DHEA Plus Low by Utak Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple steroid hormone 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 707caaa3-b55d-4808-bf64-334b2bf20920 36 fields · synced May 30, 2026