FDA.reportPublic FDA data

Alere i Strep A 2 Control Swab Kit

Primary DI
10811877010200
Brand
Alere i Strep A 2 Control Swab Kit
Company
Alere Scarborough, Inc.
Model
734-080
Device description
Control Swabs intended for use only with the Alere i Strep A 2 product.
Published
2018-06-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OOIReal Time Nucleic Acid Amplification System
PGXGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2
PGXGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173653000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173653000Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab KitAlere Scarborough, Inc.2018-05-02PGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811877010200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081187701020010811877010200

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154148498
Device count
1
Kit
true
Lot or batch
true

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