← Back to catalogue

Tinaquant Ferritin Gen4

FDA UDI

Class II (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
Tinaquant Ferritin Gen4 FDA UDI
Generic Name
Ferritin IVD, kit, chemiluminescent immunoassay FDA UDI
Model / Reference
4885627190 FDA UDI

Identifiers

Catalog Number
4885627190 FDA UDI
Primary DI / UDI-DI
04015630922826 FDA UDI
510(k) Number
K100538 FDA UDI
FDA Product Code
DBF FDA UDI
GMDN Term
Ferritin IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5340 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Ferritin IVD, kit, chemiluminescent immunoassay

Tinaquant Ferritin Gen4 by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ferritin IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

K100538 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Roche Diagnostics Corp.

Sources (1)

  • FDA UDI 381ab5d7-1357-4057-9372-805cf2727c18 35 fields · synced Jun 8, 2026