FDA.reportPublic FDA data

TearLab Osmolarity Test Card

Primary DI
00853539002034
Brand
TearLab Osmolarity Test Card
Company
Tearlab Corporation
Model
100003
Published
2025-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ONDOsmolality Of Tears

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONDOsmolality Of TearsClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083184000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083184000TEARLAB OSMOLARITY SYSTEMOcusense, Inc.2009-05-14OND

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853539002034PrimaryGS10
10853539002031Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853539002034008535390020348535390020340853539002034
1085353900203110853539002031

GMDN Terms#

Term, Definition table
TermDefinition
Osmolality 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 quantitative measurement of osmolality of a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
155813749
Device count
100000
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853539002041Osmolarity Normal Control Solutions1000122024-01-05
00853539002058Osmolarity High Control Solution1000132024-01-05
00853539002188ScoutPro Osmolarity System1000942022-12-06
10853539002048Osmolarity Normal Control Solutions1000122024-01-05
10853539002055Osmolarity High Control Solution1000132024-01-05
10853539002185ScoutPro Osmolarity System1000942022-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00853539002188ScoutPro Osmolarity SystemTearlab CorporationOND2022-12-06
10853539002185ScoutPro Osmolarity SystemTearlab CorporationOND2022-12-06