Walgreens

Primary DI
00311917070001
Company
WALGREEN CO.
Model
716583
Device description
WALG Vaginal Screen Kit 2S X
Published
2026-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Regulatory Flags

DUNS number
008965063
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00311917070001PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00311917070001PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
CENDye-Indicator, Ph (Urinary, Non-Quantitative)1Clinical Chemistry862.1550NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Vaginal pH screening IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or semi-quantitative determination of the pH range of vaginal secretions.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

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