N/T Rheumatology Control SL/2

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name: N/T Rheumatology Control SL/2 FDA UDI
Generic Name: Rheumatoid factor IVD, control FDA UDI
Device Name: Assayed control for RF ASL and CRP assays on Siemens Systems FDA UDI
Model / Reference: 10446043 FDA UDI
Description: Assayed control for RF ASL and CRP assays on Siemens Systems FDA UDI

Identifiers

Catalog Number: OQDC13 FDA UDI
Primary DI / UDI-DI: 00842768007279 FDA UDI
510(k) Number: K021381 FDA UDI
FDA Product Code: JJY FDA UDI
GMDN Term: Rheumatoid factor IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Rheumatoid factor IVD, control

N/T Rheumatology Control SL/2 by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rheumatoid factor IVD, control.

IMMUNO-TROL — THERADIAG SA
Optilite® Rheumatoid Factor Control Pack — The Binding Site Group · Class I
Liquichek — Bio-Rad Laboratories · Class II
Audit MicroControls Linearity LQ RF/CRP — Aalto Scientific, Ltd.
Liquichek — Bio-Rad Laboratories · Class II
Liquichek — Bio-Rad Laboratories · Class II
Liquichek — Bio-Rad Laboratories · Class II
RHEUMATOID FACTOR LINEARITY VERIFIERS (For Roche Systems) (RFLV) — Randox Laboratories, Ltd. · Class I

Cleared under the same submission

K021381 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: Siemens Healthcare Diagnostics Products Ltd

Sources (1)

FDA UDI 5c22045d-158a-4187-8a63-958fd0862259 37 fields · synced Jun 8, 2026