FDA.report

Easy Talk Control Solution - HIGH

Primary DI
00891237001522
Brand
Easy Talk Control Solution - HIGH
Company
HOME AIDE DIAGNOSTICS, INC.
Model
GOD31
Catalog number
1522
Device description
Blood glucose control solution for use with Easy Talk blood glucose testing system
Published
2016-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications

CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10891237001529PackageGS1100In Commercial Distribution
20891237001526PackageGS120In Commercial Distribution
00891237001522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1089123700152910891237001529
2089123700152620891237001526
00891237001522008912370015228912370015220891237001522

GMDN Terms

TermDefinition
Glucose IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.

Device Sizes

TypeValueUnit
Total Volume3Milliliter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at temperatures between 46-86oF (8-30oC).

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-915-0116info@homeaide.us

Regulatory Flags

DUNS number
783518983
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
true
Kit
false
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

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