FDA.reportPublic FDA data

Dario 300 Test Strips Bundle

Primary DI
00850065006567
Brand
Dario 300 Test Strips Bundle
Company
LABSTYLE INNOVATION LTD
Model
1212-05
Device description
The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
Published
2020-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
CGAGlucose Oxidase, Glucose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150817000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150817000Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd.2015-12-21NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850065006567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850065006567008500650065678500650065670850065006567

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, kit, enzyme spectrophotometry, rapidA collection of reagents, and sometimes other associated materials, intended to be used for the quantitative measurement of glucose in a clinical specimen within a short period relative to standard laboratory testing procedures, using an enzyme spectrophotometry method. It is available in a variety of forms (e.g., strips, cartridges, micro-cassettes) and may be used in the laboratory, at the point-of-care, and/or in the home.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600039072
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850065006444Dario Blood Glucose Monitoring System & Dario Membership1173-052019-11-06
00850065006161Dario Blood Glucose Monitoring System1015-052019-02-07
00850065006246Dario Starter Kit1146-052018-10-28
00850065006741Dario® USB-C Blood Glucose Monitoring System- Welcome Kit1264-052023-12-21
00850065006758Dario® USB-C Blood Glucose Monitoring System - Starter Kit1265-052023-12-21
00850065006390Dario® USB-C Blood Glucose Monitoring System1152-052019-10-28
00850065006406Dario® USB-C Blood Glucose Monitoring System - Starter Kit1200-052019-10-28
00850065006222Dario 100 Sterile Lancets1121-052021-08-10
00850065006659Dario Super Saver MIB-Supplies1216-052021-07-15
0085006500601750 Dario Blood Glucose Test Strip 1024-012017-06-12
00850065006024100 Blood Glucose Test Strip1074-012017-06-12
00850065006048Dario Glucose Control Solution1054-012017-06-12
0085006500610925 Blood Glucose Test Strip1105-052017-06-12
00850065006574Dario 200 Test Strips Bundle1213-052020-08-26
00850065006505Dario USB-C Blood Glucose Monitoring System & Dario Membership1193-052020-02-24
00850065006451Dario LC Blood Glucose Monitoring System & Dario Membership1183-052019-11-06
00850065006253Dario LC Starter Kit1147-052018-10-28
00850065006000Dario Blood Glucose Monitoring System1015-012017-06-12
00850065006154Dario LC Blood Glucose Monitoring System1138-052018-04-26
0085006500617825 Blood Glucose Test Strip1120-052018-04-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04719869706942Tyson Bio AC500 PRO Control Solution (Level 1) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706959Tyson Bio AC500 PRO Control Solution (Level 3) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
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00383568100857CareLiving Blood Glucose Test Strips 50ct Care Living Diagnostics Inc.CGA2023-11-15
00383568100710CareLiving MM1100 Blood Glucose Monitoring SystemCare Living Diagnostics Inc.CGA2023-11-14
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