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Diabetes Antigen Control (Unassayed)

FDA UDI

Class I (US FDA UDI)

by Mercodia AB

Identity

Trade Name
Diabetes Antigen Control (Unassayed) FDA UDI
Generic Name
Multiple insulin synthesis pathway analyte IVD, control FDA UDI
Device Name
Mercodia Diabetes Antigen Control is designed to be used as a two-level control for human insulin, C-peptide and proinsulin. It is manufactured from human serum and human insulin, C-peptide and proinsulin. FDA UDI
Model / Reference
10-1134-01 FDA UDI
Description
Mercodia Diabetes Antigen Control is designed to be used as a two-level control for human insulin, C-peptide and proinsulin. It is manufactured from human serum and human insulin, C-peptide and proinsulin. FDA UDI

Identifiers

Catalog Number
10-1134-01 FDA UDI
Primary DI / UDI-DI
07350108630078 FDA UDI
FDA Product Code
OHQ FDA UDI
GMDN Term
Multiple insulin synthesis pathway analyte 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

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 insulin synthesis pathway analyte IVD, control

Diabetes Antigen Control (Unassayed) by Mercodia AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple insulin synthesis pathway analyte IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mercodia AB

Sources (1)

  • FDA UDI fc872c3b-547a-407e-a47b-309be21ec9d3 36 fields · synced May 30, 2026