FDA.reportPublic FDA data

Tris Buffered Saline

Primary DI
G0561009910
Brand
Tris Buffered Saline
Company
Bio/Data Corporation
Model
100991
Catalog number
100991
Published
2023-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JPASystem, Multipurpose For In Vitro Coagulation Studies

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPASystem, Multipurpose For In Vitro Coagulation StudiesHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K761172000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K761172000TRIS BUFFERED SALINEBio/Data Corp.1977-01-10JPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G0561009910PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Buffered isotonic saline reagent IVDA buffered isotonic saline solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
051392959
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G0561076501AGG/PAK 5 Combo Kit1076501076502024-10-01
G0561059771Stir Bars, Macro1059771059772023-08-30
G0561059901Stir Bars, Micro1059901059902023-08-30
G0561003361Test Tubes, Macro1003361003362023-08-30
G0561009890Calcium Chloride10098910099892023-08-30
G0561009940Sodium Citrate1009941009942023-08-30
G0561013751Profiler Paper1013751013752023-08-30
G0561015211Test Tubes, Micro1015211015212023-08-30
G0561055981Printer Paper1055981055982023-08-30
G0561060771Platelet Aggregometer ProfilerPAP-8E1060772023-08-30
G0561068421PDQ Platelet Centrifuge1068421068422023-08-30
G0561068521Transfer Pipettes, Disposable1068521068522023-08-30
G0561068531Sample Tubes1068531068532023-08-30
G0561068991Sample Tube Caps1068991068992023-08-30
G0561071170LTA Check Test Kit1071171071172023-08-30
G0561071461MagneTube1071461071462023-08-30
G0561071490LTA Check CD1071491071492023-08-30
G0561071530PAP-8E Software CD1071531070532023-08-30
G0561060751Platelet Aggregometer ProfilerPAP8E1060752022-03-23
G0561013101PAR/PAK II1013101013102022-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000558185CLOTtrac™MEDTRONIC, INC.JPA2026-02-22
00763000558291RACTMEDTRONIC, INC.JPA2026-02-22
20763000558189CLOTtrac™MEDTRONIC, INC.JPA2026-02-22
20763000558295RACTMEDTRONIC, INC.JPA2026-02-22
04987562499700Automated Blood Coagulation Analyzer CN-3000SYSMEX CORPORATIONJPA2025-12-19
04987562518616Automated Blood Coagulation Analyzer CN-3000SYSMEX CORPORATIONJPA2025-12-19
08426951011223HemosIL CL TriggersINSTRUMENTATION LABORATORY COMPANYJPA2025-10-02
08426951326594HemosIL CL Rinse solutionINSTRUMENTATION LABORATORY COMPANYJPA2025-10-02
08430793045476ACL TOP 970 CLINSTRUMENTATION LABORATORY COMPANYJPA2025-10-02
08430793058322HemosIL CL Probe ConditionerINSTRUMENTATION LABORATORY COMPANYJPA2025-10-02
04987562499687Automated Blood Coagulation Analyzer CN-6000SYSMEX CORPORATIONJPA2025-08-22
04987562518630Automated Blood Coagulation Analyzer CN-6000SYSMEX CORPORATIONJPA2025-08-22
10812747018531Global Hemostasis - HNHAEMONETICS CORPORATIONJPA2024-04-10
20812747018538Global Hemostasis - HNHAEMONETICS CORPORATIONJPA2024-04-10
00630414639772Standard Human PlasmaSiemens Healthcare Diagnostics Products GmbHJPA2024-03-25
00630414640563Calcium Chloride SolutionSiemens Healthcare Diagnostics Products GmbHJPA2024-03-25
00842768018893Standard Human PlasmaSiemens Healthcare Diagnostics Products GmbHJPA2024-03-25
00842768018916Calcium Chloride SolutionSiemens Healthcare Diagnostics Products GmbHJPA2024-03-25
04987562518654Automated Blood Coagulation Analyzer CS-5100SYSMEX CORPORATIONJPA2024-02-22
04987562518661Automated Blood Coagulation Analyzer CS-2500SYSMEX CORPORATIONJPA2024-02-22
04987562518678Automated Blood Coagulation Analyzer CA-600 series CA-620SYSMEX CORPORATIONJPA2024-02-22
00810149090622R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149091681R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149092619R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149092626R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149092749R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149093258R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149095542R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149096969R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
G0561009940Sodium CitrateBio/Data CorporationJPA2023-08-30