FDA.reportPublic FDA data

TysonBio EVOLVE Blood Glucose Test Strips (50T)

Primary DI
24719869701064
Brand
TysonBio EVOLVE Blood Glucose Test Strips (50T)
Company
TYSON BIORESEARCH INC.
Model
TysonBio EVOLVE
Published
2017-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
K073492000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073492000DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEMTyson Bioresearch, Inc.2008-04-08NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719869701067PackageGS1280In Commercial Distribution
24719869701064PackageGS1560In Commercial Distribution
04719869701060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471986970106714719869701067
2471986970106424719869701064
04719869701060047198697010604719869701060

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, kit, electrometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658026104
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719869700667EZ Smart-608 Blood Glucose Test Strips (50T)EZ Smart-6082017-09-26
04719869701053TysonBio EVOLVE Blood Glucose Test Strips (25T)TysonBio EVOLVE2017-09-26
04719869701060TysonBio EVOLVE Blood Glucose Test Strips (50T)TysonBio EVOLVE2017-09-26
04719869701824Tyson Bio HT100 Blood Glucose Test Strip , 25THT1002018-07-17
04719869701831Tyson Bio HT100 Blood Glucose Test Strip , 50THT1002018-07-17
04719869701978Tyson Bio HT100-B Blood Glucose Test Strip , 50THT100-B2020-08-11
04719869701985Tyson Bio HT100-B Blood Glucose Test Strip, 25THT100-B2020-08-11
04719869702333Tyson Bio 50H Blood Glucose Test Strip, 25TTyson Bio 50H2019-03-11
04719869702340Tyson Bio 50H Blood Glucose Test Strip, 50TTyson Bio 50H2019-03-11
04719869703118TysonBio AC500 Blood Glucose Test Strips, 50TAC5002020-04-15
04719869703125TysonBio AC500 Blood Glucose Test Strips, 25TAC5002020-04-15
04719869705884Tyson Bio HS100 Blood Glucose Test StripsHS1002024-11-11
04719869705891Tyson Bio HS100 Blood Glucose Test StripsHS100 2024-11-11
04719869701992Tyson Bio HT100-B Blood Glucose Test Strip , 10THT100-B2020-08-11
04719869703132TysonBio AC500 Blood Glucose Test Strips, 10TAC5002020-04-15
04719869701497TysonBio AC200 Blood Glucose Test Strips (50T)TysonBio AC2002017-09-26
04719869701503TysonBio AC200 Blood Glucose Test Strips (25T)TysonBio AC2002017-09-26
04719869701961Tyson Bio HT100 Blood Glucose Test Strip, 10THT1002018-07-17
04719869702326Tyson Bio 50H Blood Glucose Test Strip, 10TTyson Bio 50H2019-03-11
04719869702395TysonBio AC200 Blood Glucose Test Strip, 10TTysonBio AC2002019-03-11

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