Model: PD13L
DI: 06972077026471
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
9c374e6e-8e01-42ba-8791-cb901400b712
Distribution Status:
In Commercial Distribution
DUNS Number:
530563253
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06972077026471
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 50951
Name: Escherichia coli antigen 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 antigens from Escherichia coli (E. coli) bacteria in a clinical specimen.
FDA Product Codes
KNN
Components, Wheelchair