Autokit Micro Albumin Calibrator Set

FDA UDI

Class I (US FDA UDI)

by Fujifilm Wako Pure Chemical Corporation

Identity

Trade Name: Autokit Micro Albumin Calibrator Set FDA UDI
Generic Name: Microalbumin IVD, calibrator FDA UDI
Device Name: In-Vitro Diagnostic Use FDA UDI
Model / Reference: 995-06101 FDA UDI
Description: In-Vitro Diagnostic Use FDA UDI

Identifiers

Catalog Number: 995-06101 FDA UDI
Primary DI / UDI-DI: 04987481164529 FDA UDI
510(k) Number: K030320 FDA UDI
FDA Product Code: JJX FDA UDI
GMDN Term: Microalbumin IVD, calibrator 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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: Microalbumin IVD, calibrator

Autokit Micro Albumin Calibrator Set by Fujifilm Wako Pure Chemical Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Dimension® MALB Calibrator — Siemens Healthcare Diagnostics · Class II
JAS Diagnostics — Drew Scientific , Ltd. · Class II

Cleared under the same submission

K030320 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: Fujifilm Wako Pure Chemical Corporation

Sources (1)

FDA UDI 9bb6fcb3-dbf8-4e85-aefc-90cc92d3a5ec 37 fields · synced Jun 8, 2026