FDA UDI In Commercial Distribution 🇺🇸 United States

MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control

DI: 00884883012004 · Model: OCRD-MP · Microgenics Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control
Primary DI
00884883012004
Version / Model
OCRD-MP
Company Name
Microgenics Corporation
Labeler DUNS
122153799
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-04-26
Public Version
5
Public Version Date
2024-12-30
Public Version Status
Update
Public Device Record Key
f9cd01c2-37bf-4f4e-97bb-44dcb8f62704

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
Yes
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JJY Multi-Analyte Controls, All Kinds (Assayed)

GMDN Terms

Code Name
47016 Multiple cardiac marker IVD, control

Identifiers

Type ID
Primary 00884883012004