Model: B130
DI: 06979878770275
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-16
Current Version: 2026-05-25
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c7b1ea09-8d70-411e-9442-cdc3d4b07ffa
Distribution Status:
In Commercial Distribution
DUNS Number:
979653703
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:
06979878770275
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 51457
Name: Rickettsia prowazekii immunoglobulin G (IgG) antibody IVD, reagent
Definition:
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the rickettsial bacteria Rickettsia prowazekii in a clinical specimen.
FDA Product Codes
FNL
Bed, Ac-Powered Adjustable Hospital