Model: 4P52-22
Catalog: 04P5222
DI: 00380740208622
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
Hemoglobin A1c
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c684697d-d81e-4b2c-b355-f587f4d9d450
Distribution Status:
In Commercial Distribution
DUNS Number:
315786293
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:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00380740208622
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 63151
Name: Glycated haemoglobin (HbA1c) IVD, kit, spectrophotometry
Definition:
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen, using a spectrophotometry method.
FDA Product Codes
PDJ
Hemoglobin A1c test system
LCP
ASSAY, GLYCOSYLATED HEMOGLOBIN
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
2
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
8
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling High - @attributes - Value:
30
Item #2 - Storage Handling Type:
Handling Environment Temperature