FDA.reportPublic FDA data

i-STAT

Primary DI
00054749005505
Brand
i-STAT
Company
ABBOTT POINT OF CARE INC.
Model
03P85-51
Device description
Cartridge, CG4+
Published
2020-10-05
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
KHPACID, LACTIC, ENZYMATIC METHOD
OWDSomatic gene mutation detection system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHPAcid, Lactic, Enzymatic MethodClinical Chemistry1
OWDSomatic Gene Mutation Detection SystemUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200492000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200492000i-STAT CG4+ Cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2020-04-09CHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00054749005505PackageGS125In Commercial Distribution
10054749005502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00054749005505000547490055050547490055050054749005505
1005474900550210054749005502

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 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
00816042014543FORAFORA CARE INC.KHP2025-05-06
80816042014549FORAFORA CARE INC.KHP2025-05-06
04053228034834therascreen® PDGFRA RGQ PCR KitQIAGEN GmbHOWD2024-12-10
00850014861407HeartsCare LACTATE TEST STRIPS (10PCS/BOX)Hearts Bio, Inc.KHP2024-07-08
00850014861537HeartsCare LACTATE TEST STRIPS (25PCS/BOX)Hearts Bio, Inc.KHP2024-07-08
05700699460509SC90 50 BG, LYT, MET, OXI + QCRadiometer Medical ApSKHP2024-07-01
00380740158392ARCHITECTABBOTT IRELANDKHP2024-01-24
00380740158408AlinityABBOTT IRELANDKHP2024-01-24
00816042014505FORAFORA CARE INC.KHP2023-10-31
00850014861360HeartsCare C1 LACTATE TEST STRIPS (10PCS/BOX)Hearts Bio, Inc.KHP2023-08-08
06971674866756BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KHP2023-07-22
06971674866763BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KHP2023-07-22
00630414610979Atellica CH Lactate_3Siemens Healthcare Diagnostics Inc.KHP2023-05-10
10385480408131Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
00385480408141Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
00385480408158Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
00385480626248Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
10054749005502i-STATABBOTT POINT OF CARE INC.KHP2020-10-05
00630414606460epoc Host2Epocal IncKHP2020-07-15
04053228035725therascreen® BRAF RGQ PCR KitQIAGEN GmbHOWD2020-06-11
00630414286143RAPIDPoint® 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.KHP2020-04-15
05700699441362S8377 REF 944-136 *6 Cleaning solution Met II SolutionRadiometer Medical ApSKHP2018-09-21
05700699055903Disposable Waste Container D512 REF 905-590Radiometer Medical ApSKHP2018-09-21
05700699058027Disposable Waste Container D513 REF 905-802Radiometer Medical ApSKHP2018-09-21
05700699059178REF 905-917 ABL90 FLEX sBOXRadiometer Medical ApSKHP2018-09-21
05700699059185905-918 ABL90 FLEX flush deviceRadiometer Medical ApSKHP2018-09-21
05700699059567REF 905-956 ABL90 FLEX sBOX PLUSRadiometer Medical ApSKHP2018-09-21
05700699250476925-047 ABL90 FLEX inlet clipRadiometer Medical ApSKHP2018-09-21
05700699439062S5362 REF 943-906Radiometer Medical ApSKHP2018-09-21
05700699441232Cleaning Solution with additive S7375 REF 944-123Radiometer Medical ApSKHP2018-09-21