Model: 3001-3822U2
DI: 10608337001850
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
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:
2d7b09b0-1e7d-46bc-b270-8d7c7fd35a2e
Distribution Status:
In Commercial Distribution
DUNS Number:
114152184
Device Count:
2
DM Exempt:
Yes
Premarket Exempt:
No
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
Item #1 - Pkg Type:
Shipper Box
Item #1 - Device ID:
20608337001857
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
24
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10608337001850
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10608337001850
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
00608337001853
Item #3 - Device ID Type:
Unit of Use
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 65848
Name: HIV1/HIV2 antibody IVD, kit, rapid ICT, self-testing
Definition:
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment.
FDA Product Codes
QSS
Hiv Self-Tests
Premarket Submissions
Submission Number:
BP120001
Supplement Number:
780
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:
27
Storage Handling - Storage Handling Type:
Storage Environment Temperature