Device
These dry swabs are identical in design and function to those included in the statID Pro assay kit (783025) and are being made available separately to support customer workflow nee...
Manufacturer
MERIDIAN BIOSCIENCE, INC.
MERIDIAN BIOSCIENCE, INC.
Model: 783110
Catalog: 783110
DI: 00840733101595
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Description
These dry swabs are identical in design and function to those included in the statID Pro assay kit (783025) and are being made available separately to support customer workflow needs.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
f4d0c854-eadd-4401-8923-5e7cefd3550e
Distribution Status:
In Commercial Distribution
DUNS Number:
092815364
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
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:
00840733101595
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 65459
Name: Oral/upper respiratory tract specimen collection swab IVD
Definition:
An in vitro diagnostic device in the form of a piece of absorbent or non-absorbent material, with no additives, detached or on a stick, and intended to be used by a healthcare professional for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for in vitro diagnostic investigation. This is a single-use device.
FDA Product Codes
None
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
2
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
30
Storage Handling - Storage Handling Type:
Handling Environment Temperature