FDA.reportPublic FDA data

i-STAT

Primary DI
10054749005069
Brand
i-STAT
Company
ABBOTT POINT OF CARE INC.
Model
04X64-25
Device description
I-STAT TBI PLASMA CARTRIDGE
Published
2021-10-12
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
QATBrain trauma assessment test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QATBrain Trauma Assessment TestImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201778000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201778000i-STAT TBI Plasma cartridge with the i-STAT Alinity SystemAbbott Laboratories2021-01-08QAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00054749005062PackageGS125In Commercial Distribution
10054749005069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00054749005062000547490050620547490050620054749005062
1005474900506910054749005069

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyser IVD, point-of-careA portable, electrically-powered instrument intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technology(ies) [e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence]. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes.

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
079226216
Device count
1
DM exempt
true
Lot or batch
true
Serial number
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
10054749000149i-STAT03P86-2503P86-252016-09-09
10054749000170i-STAT03P89-2403P89-242016-09-09
10054749000187i-STAT03P90-2503P90-252016-09-09
10054749000200i-STAT03P92-2503P92-252016-09-09
10054749000217i-STAT03P93-2503P93-252016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03573026626891VIDAS® TBI (GFAP, UCH-L1)BIOMERIEUX SAQAT2024-10-31
10054749005779i-STAT TBI cartridgeAbbott Point of Care Inc.QAT2024-07-08
00054749005772i-STAT TBI cartridgeAbbott Point of Care Inc.QAT2024-07-08
00380740213947ARCHITECTAbbott Ireland DiagnosticsQAT2024-03-15
00380740213954ARCHITECTAbbott Ireland DiagnosticsQAT2024-03-15
00380740209469AlinityAbbott Ireland DiagnosticsQAT2023-07-11
00380740209490AlinityAbbott Ireland DiagnosticsQAT2023-07-11
00054749005611i-STATABBOTT POINT OF CARE INC.QAT2021-10-12
00054749005062i-STATABBOTT POINT OF CARE INC.QAT2021-10-12