Autokit Micro Albumin Control Set

FDA UDI

Class I (US FDA UDI)

by Fujifilm Wako Pure Chemical Corporation

Identity

Trade Name: Autokit Micro Albumin Control Set FDA UDI
Generic Name: Albumin IVD, control FDA UDI
Device Name: In-Vitro Diagnostic Use FDA UDI
Model / Reference: 991-06201 FDA UDI
Description: In-Vitro Diagnostic Use FDA UDI

Identifiers

Catalog Number: 991-06201 FDA UDI
Primary DI / UDI-DI: 04987481164673 FDA UDI
510(k) Number: K030320 FDA UDI
FDA Product Code: JJX FDA UDI
GMDN Term: Albumin 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

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: Albumin IVD, control

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

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Also classified as Albumin IVD, control.

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Albumin control slides — BIO SB, INC. · Class I
Albumin Control Slides — BIO SB, INC. · Class I
IMMULITE® Systems ALB Calibration Verification Material Albumin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
Optilite® Low Level Albumin Control Pack — The Binding Site Group · Class I
IMMULITE® Systems ALB CONTROL Albumin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Eurotrol AlbuTrol — Eurotrol B.V. · Class I

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 797c549e-b475-4a71-8187-b3194a94ac99 37 fields · synced May 30, 2026