Dako

FDA UDI

Class I (US FDA UDI)

by Agilent Technologies Singapore Pte Ltd

Identity

Trade Name: Dako FDA UDI
Generic Name: Cystatin C IVD, calibrator FDA UDI
Device Name: Cystatin C Calibrator FDA UDI
Model / Reference: X0974 FDA UDI
Description: Cystatin C Calibrator FDA UDI

Identifiers

Primary DI / UDI-DI: 05700572014294 FDA UDI
FDA Product Code: JJX FDA UDI
NDY FDA UDI
JIT FDA UDI
GMDN Term: Cystatin C IVD, calibrator FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
862.1225 FDA UDI
862.1150 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

Dimensions & Sizes

Size: Total Volume — 1 Milliliter FDA UDI

Category: Cystatin C IVD, calibrator

Dako by Agilent Technologies Singapore Pte Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cystatin C IVD, calibrator.

K-ASSAY® Cystatin C Calibrator — KAMIYA BIOMEDICAL COMPANY, LLC · Class II
CYSTATIN C CALIBRATOR (CYSC CAL) — Randox Laboratories, Ltd. · Class II
Yumizen C1200 Cystatin C Cal — Horiba Abx · Class II
Diazyme — Diazyme Laboratories, Inc.
ADVIA Cystatin C_2 Calibrator — Siemens Healthcare Diagnostics · Class II
CYSC CAL — Randox Laboratories, Ltd. · Class II
Cystatin C Calibrators — Sentinel Ch. Srl · Class II
Atellica CH CYSC_2 Calibrators — Siemens Healthcare Diagnostics · Class II

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: Agilent Technologies Singapore Pte Ltd

Sources (1)

FDA UDI aea85d5b-e9b5-4b02-a258-c961cb67cc22 36 fields · synced May 30, 2026