FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740190293
Brand
ARCHITECT
Company
ABBOTT IRELAND
Model
02K9804
Catalog number
02K9804
Device description
Microalbumin Calibrators
Published
2022-05-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JISCalibrator, primary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JISCalibrator, PrimaryClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740190293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740190293003807401902933807401902930380740190293

GMDN Terms#

Term, Definition table
TermDefinition
Microalbumin IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of microalbumin in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature030 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
989964119
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740155322Alinity04T992004T99202025-12-19
00380740155339Alinity04T993004T99302025-12-19
00380740155612Alinity04T852004T85202025-12-19
00380740156718ARCHITECT04S892004S89202025-12-19
00380740195236ARCHITECT04T032004T03202025-12-19
00380740195243ARCHITECT04T033004T03302025-12-19
00380740106003ARCHITECT7K78-3507K78352025-12-12
00380740180713Alinity04U002004U00202025-10-24
00380740180720ARCHITECT04T042004T04202025-10-24
00380740204020ARCHITECT04T040104T04012025-10-24
00380740204037Alinity04U000104U00012025-10-24
00380740130572Alinity07P944007P94402020-07-03
00380740014346ARCHITECT7K64-5007K64502016-09-09
00380740155285Alinity04T822004T82202024-08-15
00380740155292Alinity04T823004T82302024-08-15
00380740155346Alinity04U302004U30202024-08-15
00380740155353Alinity04U303004U30302024-08-15
00380740155483ARCHITECT04U452004U45202024-08-15
00380740155490ARCHITECT04U453004U45302024-08-15
00380740155872ARCHITECT04T342004T34202024-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10758750033539VITROSORTHO CLINICAL DIAGNOSTICSJIS2025-12-30
15099590754495Access Total T4 II CalibratorsBeckman Coulter, Inc.JIS2025-09-19
10758750035373VITROSORTHO CLINICAL DIAGNOSTICSJIS2025-05-20
20758750035370VITROSORTHO CLINICAL DIAGNOSTICSJIS2025-05-20
05051700020534Optilite® Low Level Total Protein CalibratorTHE BINDING SITE GROUP LIMITEDJIS2024-10-30
00816426021532K-ASSAY® RF Calibrator (Ver.2)KAMIYA BIOMEDICAL COMPANY, LLCJIS2024-04-17
00630414615097Atellica CH Billirubin Calibrator (BILI CAL)Siemens Healthcare Diagnostics Inc.JIS2024-04-03
00630414313450Atellica CH Billirubin Calibrator (BILI CAL)Siemens Healthcare Diagnostics Inc.JIS2024-04-03
00630414639833INNOVANCE Heparin CalibratorSiemens Healthcare Diagnostics Products GmbHJIS2024-03-25
15099590752699Access Progesterone II CalibratorsBeckman Coulter, Inc.JIS2024-03-01
00630414611297Atellica CH RCRP CalSiemens Healthcare Diagnostics Inc.JIS2024-02-02
00630414636672Atellica CH Protein 1 Calibrator (PROT 1 CAL)Siemens Healthcare Diagnostics Inc.JIS2024-02-02
00630414305141Atellica CH RCRP CalSiemens Healthcare Diagnostics Inc.JIS2024-02-02
00630414313467Atellica CH Protein 1 Calibrator (PROT 1 CAL)Siemens Healthcare Diagnostics Inc.JIS2024-02-02
10758750034635VITROSORTHO CLINICAL DIAGNOSTICSJIS2024-01-20
20758750034632VITROSORTHO CLINICAL DIAGNOSTICSJIS2024-01-20
00380740197636AlinityAbbott GmbHJIS2023-11-04
07613336203538Anti-Tg CalSetRoche Diagnostics GmbHJIS2023-10-31
07613336175088CalSet FT4 IVRoche Diagnostics GmbHJIS2023-05-02
10758750033799VITROSORTHO CLINICAL DIAGNOSTICSJIS2023-03-28
10758750033850VITROSORTHO CLINICAL DIAGNOSTICSJIS2023-03-28
03607360047606CDT CAPILLARYS CALIBRATORS (2 Levels)SEBIAJIS2022-12-12
03607360047613CDT MINICAP CALIBRATORS ( 2 Levels)SEBIAJIS2022-12-12
10758750034642VITROSORTHO CLINICAL DIAGNOSTICSJIS2022-10-26
10758750034659VITROSORTHO CLINICAL DIAGNOSTICSJIS2022-10-24
10758750034895VITROSORTHO CLINICAL DIAGNOSTICSJIS2022-10-24
05055273204445LIPOPROTEIN (a) CONTROL (Lp (a) CONTROL 3) RANDOX LABORATORIES LIMITEDJIS2022-10-05
00817302024340CAROLINA LIQUID CHEMISTRIES CORP.® IRON STANDARD (FESTD) CC618-STDCAROLINA LIQUID CHEMISTRIES CORPORATIONJIS2022-08-19
00630414610863Atellica CH HDLC CALSiemens Healthcare Diagnostics Inc.JIS2022-07-08
00630414305165Atellica CH HDLC CALSiemens Healthcare Diagnostics Inc.JIS2022-07-08