FDA.reportPublic FDA data

i-STAT

Primary DI
00054749005512
Brand
i-STAT
Company
ABBOTT POINT OF CARE INC.
Model
09P31-26
Device description
Cartridge, Chem8+
Published
2020-05-01
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
JPIDevice, Hematocrit Measuring
OWDSomatic gene mutation detection system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPIDevice, Hematocrit MeasuringHematology2
OWDSomatic Gene Mutation Detection SystemUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183678000
K183680000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183678000i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2020-02-07CGA
K183680000i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2020-02-28JPI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00054749005512PackageGS125In Commercial Distribution
10054749005519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00054749005512000547490055120547490055120054749005512
1005474900551910054749005519

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius0
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
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
04053228034834therascreen® PDGFRA RGQ PCR KitQIAGEN GmbHOWD2024-12-10
00810022732571LeukoStratINVIVOSCRIBE, INC.OWD2023-05-30
04053228043560therascreen® FGFR RGQ RT-PCR KitQIAGEN GmbHOWD2022-05-23
00054749005505i-STATABBOTT POINT OF CARE INC.OWD2020-10-05
00875197005592cobas&#x00AE EZH2 Mutation TestRoche Molecular Systems, Inc.OWD2020-08-01
00054749005123i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005147i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005154i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005161i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005178i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005185i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005192i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005208i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005215i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005222i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005529i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
04053228035725therascreen® BRAF RGQ PCR KitQIAGEN GmbHOWD2020-06-11
00850052003739LeukoStratINVIVOSCRIBE, INC.OWD2020-06-08
00850052003685LeukoStratINVIVOSCRIBE, INC.OWD2020-05-29
10054749005519i-STATABBOTT POINT OF CARE INC.JPI2020-05-01
00054749005093i-STATABBOTT POINT OF CARE INC.OWD2019-12-20
04053228034223therascreen® PIK3CA RGQ PCR KitQIAGEN GmbHOWD2019-06-05
04053228034094therascreen® FGFR RGQ RT-PCR KitQIAGEN GmbHOWD2019-04-29
00884999047792RealTimeABBOTT MOLECULAR INC.OWD2018-08-06
00884999047341RealTimeABBOTT MOLECULAR INC.OWD2018-07-30
00884999047358RealTimeABBOTT MOLECULAR INC.OWD2018-07-30
00884999047037RealTimeABBOTT MOLECULAR INC.OWD2017-08-11
00884999047044RealTimeABBOTT MOLECULAR INC.OWD2017-08-11
00884999047051RealTimeABBOTT MOLECULAR INC.OWD2017-08-11
03573026559823THxID™ BRAFBIOMERIEUX SAOWD2017-05-12