Model: 09537368190
Catalog: 09537368190
DI: 07613336231432
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0826f03d-e0de-4c9a-adad-5c9e0805b746
Distribution Status:
In Commercial Distribution
DUNS Number:
315028860
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
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:
07613336231432
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 59055
Name: Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
Definition:
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to streptolysin O enzyme produced by Group A beta-haemolytic Streptococcus bacteria in a clinical specimen, using a nephelometry/turbidimetry method.
FDA Product Codes
GTQ
ANTISTREPTOLYSIN - TITER/STREPTOLYSIN O REAGENT