Model: 51070(T2000)
DI: 06972077026280
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
e70a563a-64c1-458f-82c0-dc7fd8d84da2
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:
06972077026280
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 51484
Name: Rickettsia rickettsii immunoglobulin G (IgG) antibody IVD, control
Definition:
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the rickettsial bacteria Rickettsia rickettsii in a clinical specimen.
FDA Product Codes
INW
Table, Mechanical