Model: 09465022190
Catalog: 09465022190
DI: 07613336234457
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
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
f728cc0e-8fc8-4e9e-bbcd-5c0a4f888a16
Distribution Status:
In Commercial Distribution
DUNS Number:
315028860
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
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:
07613336234457
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 59863
Name: Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay
Definition:
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Treponema pallidum in a clinical specimen using a chemiluminescent immunoassay method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.
FDA Product Codes
JJX
Single (specified) analyte controls (assayed and unassayed)
Premarket Submissions
Submission Number:
K160910
Supplement Number:
000