MMA (Methylmalonic Acid) Level 2

FDA UDI

Class I (US FDA UDI)

by Utak Laboratories, Inc.

Identity

Trade Name: MMA (Methylmalonic Acid) Level 2 FDA UDI
Generic Name: Methylmalonic acid (MMA) IVD, control FDA UDI
Device Name: MMA (Methylmalonic Acid) Level 2 FDA UDI
Model / Reference: 74054 FDA UDI
Description: MMA (Methylmalonic Acid) Level 2 FDA UDI

Identifiers

Catalog Number: 74054 FDA UDI
Primary DI / UDI-DI: B800740540 FDA UDI
FDA Product Code: LAS FDA UDI
GMDN Term: Methylmalonic acid (MMA) 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 5 Milliliter FDA UDI

Category: Methylmalonic acid (MMA) IVD, control

MMA (Methylmalonic Acid) Level 2 by Utak Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Methylmalonic acid (MMA) IVD, control.

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Pasma Control — Chromsystems Instruments & Chemicals GmbH · Class I
Plasma Control Bi-Level — Chromsystems Instruments & Chemicals GmbH · Class I
Urine Control — Chromsystems Instruments & Chemicals GmbH · Class I
MMA (Methylmalonic Acid) Level 1 — UTAK LABORATORIES, INC. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Utak Laboratories, Inc.

Sources (1)

FDA UDI b6fc4c79-66b4-4e36-beb4-a8950e8c469f 37 fields · synced Jun 8, 2026