Device
Consumable for the performance of a molecular diagnostic test (PCR), https://techdocs.quidelortho.com/
Manufacturer
LEX DIAGNOSTICS LIMITED
LEX DIAGNOSTICS LIMITED
Model: 200003
Catalog: 200003
DI: 05061098480025
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
Description
Consumable for the performance of a molecular diagnostic test (PCR), https://techdocs.quidelortho.com/
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b89c78df-3616-4d5a-bfed-d84817589adb
Distribution Status:
In Commercial Distribution
DUNS Number:
225696216
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:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
Carton
Item #1 - Device ID:
15061098480022
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
50
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
05061098480025
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
05061098480025
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
Shipping Unit
Item #3 - Device ID:
25061098480029
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
2
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
15061098480022
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 62392
Name: Oral/respiratory tract specimen container IVD, additive/medium
Definition:
A covered receptacle containing an additive and/or medium [e.g., saline, sodium azide, buffer solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)] intended to be used in the home and clinical settings for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, oropharyngeal, and/or lower respiratory tract specimen (e.g., sputum) [excluding breath specimen], for in vitro diagnostic investigation (e.g., COVID-19 screening). It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.
FDA Product Codes
QOF
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Premarket Submissions
Submission Number:
K251742
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
2
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
8
Item #1 - Storage Handling Type:
Handling Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling Low - @attributes - Value:
15
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling High - @attributes - Value:
30
Item #2 - Storage Handling Type:
Storage Environment Temperature
Item #3 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #3 - Storage Handling Low - @attributes - Value:
10
Item #3 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #3 - Storage Handling High - @attributes - Value:
90
Item #3 - Storage Handling Type:
Storage Environment Humidity