Calcium Gen.2

FDA UDI

Class II (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name: Calcium Gen.2 FDA UDI
Generic Name: Calcium (Ca2+) IVD, kit, spectrophotometry FDA UDI
Model / Reference: 08057427190 FDA UDI

Identifiers

Catalog Number: 08057427190 FDA UDI
Primary DI / UDI-DI: 07613336121092 FDA UDI
510(k) Number: K113521 FDA UDI
FDA Product Code: CHW FDA UDI
GMDN Term: Calcium (Ca2+) IVD, kit, spectrophotometry FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1145 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: Calcium (Ca2+) IVD, kit, spectrophotometry

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

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Cleared under the same submission

K113521 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 II	Pending data

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Manufacturer

Manufacturer: Roche Diagnostics Corp.

Sources (1)

FDA UDI bb1b4f8a-2820-42b5-b4a1-c6bb543fcadb 35 fields · synced May 30, 2026