FDA.reportPublic FDA data

i-STAT

Primary DI
00054749005062
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
Multichannel clinical chemistry analyser IVD, point-of-care, battery-poweredA portable, battery-powered instrument intended to be used by health professionals at the point-of-care to analyse a clinical specimen for the qualitative and/or quantitative determination of multiple clinical chemistry analytes simultaneously from multiple analytical processes. Analytes measured may include electrolytes, specific proteins, lipids, and kidney, liver and/or cardiac function test analytes using two or more technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
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
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
10054749005069i-STATABBOTT POINT OF CARE INC.QAT2021-10-12
00054749005611i-STATABBOTT POINT OF CARE INC.QAT2021-10-12