FDA.reportPublic FDA data

i-STAT

Primary DI
10054749001009
Brand
i-STAT
Company
ABBOTT POINT OF CARE INC.
Model
05p58-25
Catalog number
05p58-25
Device description
CARTRIDGE, Total B-hCG
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
CHLELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
DHASystem, Test, Human Chorionic Gonadotropin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhClinical Chemistry2
DHASystem, Test, Human Chorionic GonadotropinClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133002000i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification MaterialsAbbott Point of Care, Inc.2015-04-16DHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00054749001002PackageGS125In Commercial Distribution
10054749001009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00054749001002000547490010020547490010020054749001002
1005474900100910054749001009

GMDN Terms#

Term, Definition table
TermDefinition
Total human chorionic gonadotropin IVD, reagentA substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen.

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
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
20612479280124McKessonMCKESSON MEDICAL-SURGICAL INC.DHA2025-12-10
00380740215712AlinityABBOTT LABORATORIESDHA2025-10-08
20612479279715McKessonMCKESSON MEDICAL-SURGICAL INC.DHA2025-09-10
10758750034291VITROSORTHO CLINICAL DIAGNOSTICSDHA2024-09-18
00054749005673i-STAT G3+ CartridgeAbbott Point of Care Inc.CHL2023-12-18
15099590744380Access Total BhCG (5th IS)Beckman Coulter, Inc.DHA2023-01-06
00385480534437Stat Profile NOVA BIOMEDICAL CORPORATIONCHL2022-12-08
00385480563079Stat Profile NOVA BIOMEDICAL CORPORATIONCHL2022-12-08
00385480574549Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2022-12-08
00385480574587Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2022-12-08
00385480596961Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2022-12-08
00385480616218Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2022-12-07
00385480616058Stat Profile NOVA BIOMEDICAL CORPORATIONCHL2022-06-16
00385480642514Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2022-06-06
00385480646048Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2022-06-06
08806388243310Multi-unit Angled AbutmentMegagen Implant Co. LtdDHA2021-11-17
10054749005502i-STATABBOTT POINT OF CARE INC.CHL2020-10-05
00630414286143RAPIDPoint® 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.CHL2020-04-15
00385480614535Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03
00385480614542Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03
00385480623384Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03
00385480623414Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03
00385480623421Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03
00385480623438Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03
00385480623506Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03
00385480623513Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03
00385480623520Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03
00385480623537Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03
00385480626323Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03
00385480626347Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03