Device
The Multi-Analyte Chemistry calibrator is for use as a calibrator of Pointe Scientific Inc. clinical chemistry assays. This calibrator material is well suited for automated and sem...
Manufacturer
HORIBA INSTRUMENTS INCORPORATED
HORIBA INSTRUMENTS INCORPORATED
Model: C7506-15
Catalog: C7506-15
DI: 00811727018977
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
The Multi-Analyte Chemistry calibrator is for use as a calibrator of Pointe Scientific Inc. clinical chemistry assays. This calibrator material is well suited for automated and semi-automated analytical procedures.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c551cf69-c22f-4ba2-9242-d415eb94c9ee
Distribution Status:
In Commercial Distribution
DUNS Number:
052845583
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:
00811727018977
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
JIX
Calibrator, Multi-Analyte Mixture
Premarket Submissions
Submission Number:
K070207
Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
2
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
8
Storage Handling - Storage Handling Type:
Storage Environment Temperature