FDA.reportPublic FDA data

i-STAT

Primary DI
10054749000149
Brand
i-STAT
Company
ABBOTT POINT OF CARE INC.
Model
03P86-25
Catalog number
03P86-25
Device description
Celite ACT CARTRIDGE
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JBPACTIVATED WHOLE BLOOD CLOTTING TIME

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JBPActivated Whole Blood Clotting TimeHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992571000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992571000I-STAT SYSTEMI-Stat Corp.2000-02-10JBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00054749000142PackageGS125In Commercial Distribution
10054749000149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00054749000142000547490001420547490001420054749000142
1005474900014910054749000149

GMDN Terms#

Term, Definition table
TermDefinition
Activated clotting time (ACT) IVD, kit, clottingA collection of reagents and other associated materials intended to be used for the quantitative measurement of the activated clotting time (ACT) of a clinical specimen, using a clotting method.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)366-8020techsvc@apoc.abbott.com

Regulatory Flags#

DUNS number
079226216
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
10054749005519i-STAT09P31-2609P31-262020-05-01
10054749000163i-STAT03P88-2503P88-252016-09-09
10054749000132i-STAT03P85-2503P85-252016-09-09
00054749004027i-STAT06F24-2006F24-202023-09-22
00054749001385i-STAT06F24-1606F24-162023-06-23
00054749004911i-STAT hs-TnI Calibration Verification, Levels 1-306P17-2006P17-202025-05-02
00054749004928i-STAT hs-TnI Control Level 106P17-2106P17-212025-05-02
00054749004935i-STAT hs-TnI Control Level 206P17-2206P17-222025-05-02
00054749004942i-STAT hs-TnI Control Level 306P17-2306P17-232025-05-02
10054749003058i-STAT hs-TnI cartridge09P81-2509P81-252025-04-29
00054749003051i-STAT hs-TnI cartridge09P81-2509P81-252025-04-29
10054749005779i-STAT TBI cartridge03S09-2503S09-252024-07-08
00054749005772i-STAT TBI cartridge03S09-2503S09-252024-07-08
00054749000661i-STAT06F14-0106F14-012023-06-23
10054749000071i-STAT03P79-2503P79-252016-09-09
10054749000170i-STAT03P89-2403P89-242016-09-09
10054749000187i-STAT03P90-2503P90-252016-09-09
10054749000200i-STAT03P92-2503P92-252016-09-09
10054749000217i-STAT03P93-2503P93-252016-09-09
10054749000118i-STAT03P83-2503P83-252016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000558338HR HTCMEDTRONIC, INC.JBP2026-02-23
20763000558332HR HTCMEDTRONIC, INC.JBP2026-02-23
00763000558192CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
00763000558208CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
00763000558215CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
00763000558222CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
00763000558239CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
20763000558196CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
20763000558202CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
20763000558219CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
20763000558226CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
20763000558233CLOTtrac™MEDTRONIC, INC.JBP2026-02-22
B558DP29510Sonoclot® Coagulation & Platelet Function AnalyzerSIENCO, INC.JBP2023-06-28
20763000433813LR-ACTMEDTRONIC, INC.JBP2023-04-08
20763000433844HR-ACTMEDTRONIC, INC.JBP2023-04-08
00763000433819LR-ACTMEDTRONIC, INC.JBP2023-04-08
00763000433840HR-ACTMEDTRONIC, INC.JBP2023-04-08
20763000441450NAMEDTRONIC, INC.JBP2023-04-07
00763000441456NAMEDTRONIC, INC.JBP2023-04-07
10711234103401GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)ACCRIVA DIAGNOSTICS HOLDINGS, INC.JBP2022-01-21
10711234103418GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR)ACCRIVA DIAGNOSTICS HOLDINGS, INC.JBP2022-01-21
00711234103404GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)ACCRIVA DIAGNOSTICS HOLDINGS, INC.JBP2022-01-21
00711234103411GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR)ACCRIVA DIAGNOSTICS HOLDINGS, INC.JBP2022-01-21
20643169730155N/AMEDTRONIC, INC.JBP2021-11-12
00643169730151N/AMEDTRONIC, INC.JBP2021-11-12
B55880004411Sonoclot® aiACT KitSIENCO, INC.JBP2021-07-19
B55880004421Sonoclot® aiACT KitSIENCO, INC.JBP2021-07-19
B55880004410Sonoclot® aiACT KitSIENCO, INC.JBP2021-07-19
B55880004420Sonoclot® aiACT KitSIENCO, INC.JBP2021-07-19
B55880004111Sonoclot® gbACT+ KitSIENCO, INC.JBP2021-05-26