← Back to catalogue

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
00856626006106 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
Not 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

Yes

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

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

Cleared under the same submission

K030320 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Fujifilm Wako Pure Chemical Corporation

Sources (1)

  • FDA UDI 32321d3e-8593-40e3-ba02-7e8cee2d8ff1 38 fields · synced May 30, 2026