Model: 1578-0891
Catalog: 1578-0891
DI: 05204309104789
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
03c41be6-f449-4252-a82f-c39de245e6f2
Distribution Status:
In Commercial Distribution
DUNS Number:
728553111
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
05204309104789
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 47868
Name: Multiple-type clinical chemistry analyte profile IVD, calibrator
Definition:
A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.
FDA Product Codes
None