Alere Reader Calibration Check Card

Primary DI
10811877011009
Brand
Alere Reader Calibration Check Card
Company
Alere Scarborough, Inc.
Model
LFR-003
Device description
A calibration check card verifies that the Alere™ Reader is functioning correctly
Published
2017-12-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162642000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162642000Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitAlere Scarborough, Inc.2017-04-10PSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811877011009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081187701100910811877011009

GMDN Terms#

Term, Definition table
TermDefinition
Optical instrument performance standard calibrator/control IVD, reusableA solid phase or liquid reference standard of known optical and physical characteristics, intended to be used to verify and/or optimise the performance of an optical instrument (e.g., spectrophotometer, nephelometer, microplate reader). It is typically presented as a solid/sealed cuvette or a multiple-well test plate and may include filters or a light source emitted at specified wavelengths. Verification/optimization functions may include optical density (absorbance/scattering), fluorescent or luminescent accuracy, linearity, repeatability and/or limit of detection readings, and the ability to verify optical alignment and precision of the instrument or analyser. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

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