Teal Wand

Primary DI
00860009467903
Brand
Teal Wand
Company
Teal Health, Inc.
Model
90-001
Published
2026-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
SEPDevice For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SEPDevice For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular AssayMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN240045000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN240045000Teal WandTeal Health, Inc.2025-05-09SEP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009467903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009467903008600094679038600094679030860009467903

GMDN Terms#

Term, Definition table
TermDefinition
Sexually transmitted infection (STI) testing specimen collection kit IVD, home-useA collection of devices intended to be used by a layperson in the home to collect a clinical specimen for subsequent in vitro diagnostic investigation of sexually transmitted infections (STI) [e.g., Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, syphilis and human immunodeficiency virus (HIV)]. It consists of one or multiple transport containers, with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)], and sampling/collection tool(s) [e.g., vaginal, rectal or oropharyngeal swab, brush, spatula, lancet, pipette]. This is a single-use device.

Regulatory Flags#

DUNS number
044672626
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810111410670LetsGetChecked Vaginal HPV Sample Collection Kit (HPVT & HPVT2)PRIVAPATH DIAGNOSTICS LIMITEDSEP2026-08-07