FDA.reportPublic FDA data

Salimetrics

Primary DI
00859410006016
Brand
Salimetrics
Company
SALIMETRICS, LLC
Model
N/A
Catalog number
1-3102-5
Device description
Expanded Range High Sensitivity Salivary Cortisol Enzyme Immunoassay Kit (5-pack)
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NHGEnzyme Immunoassay, Cortisol, Salivary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHGEnzyme Immunoassay, Cortisol, SalivaryClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031348000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031348000HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAYSalimetrics, LLC2003-06-10NHG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859410006016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859410006016008594100060168594100060160859410006016

GMDN Terms#

Term, Definition table
TermDefinition
Total cortisol IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total cortisol in a clinical specimen, using an enzyme immunoassay (EIA) method. It is used as an aid in the diagnosis and treatment of adrenal disorders.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
084843064
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859410006351SalimetricsN/A5016.042025-12-10
00859410006368SalimetricsN/A5016.04B2025-12-10
00859410006375SalimetricsN/A5001.022025-12-10
00859410006344SalivaBioN/A5001.06B2025-11-24
00859410006283SalimetricsN/A5004.012024-12-27
00859410006290SalimetricsN/A5004.042024-12-27
00859410006306SalimetricsN/A5004.022024-12-27
00859410006313SalimetricsN/A5004.032024-12-27
00859410006320SalimetricsN/A5004.062024-12-27
00859410006337SalimetricsN/A5004.052024-12-27
00859410006269SalimetricsN/A1-44102024-09-18
00859410006276SalimetricsN/A1-4410-52024-09-18
00859410006245SalimetricsN/A1-3512-52023-09-26
00859410006252SalimetricsN/A1-35122023-09-26
00859410006139SalimetricsN/A1-23122022-08-23
00859410006177SalimetricsN/A1-2312-52022-08-23
00859410006009SalivaBioN/A5016.042022-10-13
00859410006214SalivaBioN/A5016.04B2022-10-13
00859410006221SalivaBioN/A5016.062022-10-13
00859410006238SalivaBioN/A5016.06B2022-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850039602719PantexPantexNHG2023-03-17
00850039602191PantexPantexNHG2023-02-17
00850039602023Pantex P631SCPantexNHG2022-05-23
00850039602030Pantex P631SCPantexNHG2022-05-23
00850039602047Pantex P631SCPantexNHG2022-05-23
00850039602054Pantex P631SCPantexNHG2022-05-23
00850039602061Pantex P631SCPantexNHG2022-05-23
00850039602078Pantex P631SCPantexNHG2022-05-23
00850039602085Pantex P631SCPantexNHG2022-05-23
00850039602092Pantex P631SCPantexNHG2022-05-23
00850039602108Pantex P631SCPantexNHG2022-05-23
00850039602115Pantex P631SCPantexNHG2022-05-23
00850039602122Pantex P631SCPantexNHG2022-05-23
00850039602139Pantex P631SCPantexNHG2022-05-23
00850039602146Pantex P631SCPantexNHG2022-05-23
00850039602153Pantex UniversalPantexNHG2022-05-23
00850039602009Pantex P631SCPantexNHG2022-05-23
10850039602020Pantex P631SCPantexNHG2022-05-23
10850039602037Pantex P631SCPantexNHG2022-05-23
10850039602044Pantex P631SCPantexNHG2022-05-23
10850039602051Pantex P631SCPantexNHG2022-05-23
10850039602068Pantex P631SCPantexNHG2022-05-23
10850039602075Pantex P631SCPantexNHG2022-05-23
10850039602082Pantex P631SCPantexNHG2022-05-23
10850039602099Pantex P631SCPantexNHG2022-05-23
10850039602105Pantex P631SCPantexNHG2022-05-23
10850039602112Pantex P631SCPantexNHG2022-05-23
10850039602129Pantex P631SCPantexNHG2022-05-23
10850039602136Pantex P631SCPantexNHG2022-05-23
10850039602143Pantex P631SCPantexNHG2022-05-23