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Clinitek Novus® Cal 1-4 kit

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Clinitek Novus® Cal 1-4 kit FDA UDI
Generic Name
Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, calibrator FDA UDI
Device Name
Clinitek Novus® calibration kit for use with CLINITEK Novus® automated urine chemistry system FDA UDI
Model / Reference
10697753 FDA UDI
Description
Clinitek Novus® calibration kit for use with CLINITEK Novus® automated urine chemistry system FDA UDI

Identifiers

Catalog Number
10697753 FDA UDI
Primary DI / UDI-DI
00630414590950 FDA UDI
510(k) Number
K140717 FDA UDI
FDA Product Code
JMT FDA UDI
KQO FDA UDI
JIX FDA UDI
JJB FDA UDI
CDM FDA UDI
JIO FDA UDI
JIL FDA UDI
JIN FDA UDI
JIR FDA UDI
LJX FDA UDI
CEN FDA UDI
JRE FDA UDI
GMDN Term
Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, calibrator FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1510 FDA UDI
862.2900 FDA UDI
862.1150 FDA UDI
862.1115 FDA UDI
862.1785 FDA UDI
864.6550 FDA UDI
862.1340 FDA UDI
862.1435 FDA UDI
862.1645 FDA UDI
864.7675 FDA UDI
862.1550 FDA UDI
862.2800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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: Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, calibrator

Clinitek Novus® Cal 1-4 kit by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K140717 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI 8495137e-f0b4-47e7-88f7-d8009fb3f3c2 37 fields · synced Jun 8, 2026