Magnesium Gen.2

FDA UDI

Class I (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name: Magnesium Gen.2 FDA UDI
Generic Name: Magnesium (Mg2+) IVD, kit, spectrophotometry FDA UDI
Model / Reference: 08900019190 FDA UDI

Identifiers

Catalog Number: 08900019190 FDA UDI
Primary DI / UDI-DI: 07613336169438 FDA UDI
510(k) Number: K983416 FDA UDI
FDA Product Code: JGJ FDA UDI
GMDN Term: Magnesium (Mg2+) IVD, kit, spectrophotometry FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1495 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Magnesium (Mg2+) IVD, kit, spectrophotometry

Magnesium Gen.2 by Roche Diagnostics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K983416 also covers:

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: Roche Diagnostics Corp.

Sources (1)

FDA UDI 0e2309ff-4742-4321-a013-b516b61db346 35 fields · synced May 30, 2026