FDA.reportPublic FDA data

Osmolarity High Control Solution

Primary DI
00853539002058
Brand
Osmolarity High Control Solution
Company
Tearlab Corporation
Model
100013
Published
2024-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853539002058PrimaryGS10
10853539002055Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853539002058008535390020588535390020580853539002058
1085353900205510853539002055

GMDN Terms#

Term, Definition table
TermDefinition
Osmolality IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of osmolality of a clinical specimen.

Regulatory Flags#

DUNS number
155813749
Device count
500
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853539002034TearLab Osmolarity Test Card1000032025-08-28
00853539002041Osmolarity Normal Control Solutions1000122024-01-05
00853539002188ScoutPro Osmolarity System1000942022-12-06
10853539002048Osmolarity Normal Control Solutions1000122024-01-05
10853539002055Osmolarity High Control Solution1000132024-01-05
10853539002185ScoutPro Osmolarity System1000942022-12-06