FDA.reportPublic FDA data

Alinity

Primary DI
00380740151294
Brand
Alinity
Company
Abbott GmbH
Model
04U7302
Catalog number
04U7302
Device description
ALINITY h-series HemCal
Published
2023-11-16
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
KRXCalibrator for cell indices
KRYCalibrator for platelet counting
KRZCalibrator for hemoglobin and hematocrit measurement
KSACalibrator for red-cell and white-cell counting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRXCalibrator For Cell IndicesHematology2
KRYCalibrator For Platelet CountingHematology2
KRZCalibrator For Hemoglobin And Hematocrit MeasurementHematology2
KSACalibrator For Red-Cell And White-Cell CountingHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020469000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020469000CAL-CHEX CD PLUSStreck Laboratories, Inc.2002-04-04KRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740151294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740151294003807401512943807401512940380740151294

GMDN Terms#

Term, Definition table
TermDefinition
Full blood count IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count and calculation of red cell parameters and/or platelet count.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius10 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
315786293
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740132552Alinity09P842009P84202023-11-16
00380740208622ARCHITECT4P52-2204P52222026-05-15
00380740208639Alinity08P432108P43212026-05-15
00380740193645ARCHITECT1P31-2701P31272026-04-28
00380740117207Alinity06P066006P06602019-10-12
00380740167455Alinity06P060306P06032019-10-12
00380740167462Alinity06P062006P06202019-10-12
00380740167479Alinity06P062406P06242019-10-12
00380740139032ARCHITECT06P222706P22272017-08-16
00380740139049ARCHITECT06P223706P22372017-08-16
00380740011130ARCHITECT6L23-0106L23012014-11-18
00380740189785Alinity09P262509P26252026-01-01
00380740189792ARCHITECT3P24-2803P24282026-01-01
00380740189808ARCHITECT3P24-3803P24382026-01-01
00380740189815Alinity09P263509P26352026-01-01
00380740189822Alinity09P260209P26022026-01-01
00380740189839Alinity09P261109P26112026-01-01
00380740189846ARCHITECT3P24-0203P24022026-01-01
00380740189853ARCHITECT3P24-1103P24112026-01-01
00380740223748Alinity09P261D09P261D2026-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414287201Atellica HEMA CalibratorSiemens Healthcare Diagnostics Inc.KSA2026-02-06
00630414287201Atellica HEMA CalibratorSiemens Healthcare Diagnostics Inc.KRZ2026-02-06
00630414287201Atellica HEMA CalibratorSiemens Healthcare Diagnostics Inc.KRY2026-02-06
00815762023446Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2025-12-01
00815762023453Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2025-12-01
06936415992927SC-CAL PLUSShenzhen Mindray Bio-Medical Electronics Co., Ltd.KRX2025-01-17
03610230009611ABX MinocalHORIBA ABX SASKSA2024-09-27
14987562460332XN CALSYSMEX CORPORATIONKRX2017-10-06
14987562460356XN CAL PFSYSMEX CORPORATIONKRX2017-10-06
14987562460592X-CAL CalibratorSYSMEX CORPORATIONKRX2017-10-06
D757U2260K1One Step Plus KITBISCO INC.KRX2017-06-12
00630414224343ADVIA® 120/2120/2120i SETpointSiemens Healthcare Diagnostics Inc.KRZ2016-09-24
00630414600826ADVIA® 360/560 CalibratorSiemens Healthcare Diagnostics Inc.KRZ2016-09-24
15099590221881COULTER S-CAL Beckman Coulter, Inc.KRY2016-09-23
15099590233679COULTER S-CAL Beckman Coulter, Inc.KRY2016-09-23
15099590233761COULTER S-CAL Beckman Coulter, Inc.KRY2016-09-23
15099590639426COULTER AcTBeckman Coulter, Inc.KRX2016-09-23
06944904084152SC-CAL PLUS CalibratorShenzhen Mindray Bio-Medical Electronics Co., Ltd.KRX2016-09-23
04015630921096Cfas HbA1cRoche Diagnostics GmbHKRZ2016-09-20
20844509000246Cal-ChexSTRECK, INC.KRZ2016-09-16
20844509000314Cal-Chex A Plus STRECK, INC.KRZ2016-09-16
20844509000314Cal-Chex A Plus STRECK, INC.KSA2016-09-16
20844509000314Cal-Chex A Plus STRECK, INC.KRX2016-09-16
20844509000314Cal-Chex A Plus STRECK, INC.KRY2016-09-16
30844509000243Cal-Chex STRECK, INC.KRZ2016-09-16
30844509000311Cal-Chex A Plus STRECK, INC.KRY2016-09-16
30844509000311Cal-Chex A Plus STRECK, INC.KSA2016-09-16
30844509000311Cal-Chex A Plus STRECK, INC.KRZ2016-09-16
30844509000311Cal-Chex A Plus STRECK, INC.KRX2016-09-16
40844509000318Cal-Chex A PlusSTRECK, INC.KSA2016-09-16