FDA.reportPublic FDA data

Tyson Bio HT100-B Blood Glucose Test Strip, 25T

Primary DI
04719869701985
Brand
Tyson Bio HT100-B Blood Glucose Test Strip, 25T
Company
TYSON BIORESEARCH INC.
Model
HT100-B
Published
2020-08-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170079000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170079000Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring SystemTyson Bioresearch, Inc.2017-10-06NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719869701982PackageGS1280In Commercial Distribution
24719869701989PackageGS1560In Commercial Distribution
34719869701986PackageGS1250In Commercial Distribution
04719869701985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471986970198214719869701982
2471986970198924719869701989
3471986970198634719869701986
04719869701985047198697019854719869701985

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. It is typically in a strip format (e.g., screen-printed electrode) for use with a dedicated testing device (not included).

Regulatory Flags#

DUNS number
658026104
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719869706904Tyson Bio AC500 PRO Blood Glucose Monitoring System (Meter Only) (FDA)Tyson Bio AC500 PRO2026-07-13
04719869706911TysonBio AC500 PRO Blood Glucose Test Strips (50T)Tyson Bio AC500 PRO2026-07-13
04719869706928Tyson Bio AC500 PRO Glucose Control Solution (Level 1 & Level 3)Tyson Bio AC500 PRO2026-07-13
04719869706942Tyson Bio AC500 PRO Control Solution (Level 1) (FDA)Tyson Bio AC500 PRO2026-07-13
04719869706959Tyson Bio AC500 PRO Control Solution (Level 3) (FDA)Tyson Bio AC500 PRO2026-07-13
04719869706973medisana BG 150 Blood Glucose Monitoring SystemBG 1502026-07-13
04719869706980medisana BG 150 Blood Glucose Test Strips (50Tx2)BG 1502026-07-13
04719869706997medisana BG 150 Control Solution (Level 2)BG 1502026-07-13
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00682607551354ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551361ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551378ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815234ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815241ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815258ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815265ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551385ON CALL® SURE BLOOD CONTROL SOLUTIONAcon Laboratories, Inc.NBW2026-07-30
00682607551392ON CALL® SURE BLOOD GLUCOSE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607551408ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551422ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551439ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551446ON CALL® SURE SYNC BLOOD GLUCOSE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607551453ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551460ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551477ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607815098ON CALL® SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607815104ON CALL® SURE GK BLOOD GLUCOSE & KETONE METERAcon Laboratories, Inc.NBW2026-07-30
00682607815111ON CALL® SURE SYNC GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607815272ON CALL® SURE KETONE CONTROL SOLUTIONAcon Laboratories, Inc.NBW2026-07-30
00850078377265iHealthiHealth Labs Inc.NBW2026-07-14
00860015091604KetoBMKETOBM USA LLCNBW2026-07-14
00860015091611KetoBMKETOBM USA LLCNBW2026-07-14
00860015091628KetoBMKETOBM USA LLCNBW2026-07-14
00860015091635KetoBMKETOBM USA LLCNBW2026-07-14
04719869706904Tyson Bio AC500 PRO Blood Glucose Monitoring System (Meter Only) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706911TysonBio AC500 PRO Blood Glucose Test Strips (50T)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706928Tyson Bio AC500 PRO Glucose Control Solution (Level 1 & Level 3)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706942Tyson Bio AC500 PRO Control Solution (Level 1) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706959Tyson Bio AC500 PRO Control Solution (Level 3) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13