Alinity

Primary DI
00380740151270
Brand
Alinity
Company
Abbott GmbH
Model
04U7206
Catalog number
04U7206
Device description
ALINITY h-series CONTROL 29P
Published
2023-11-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GLQMixture, control, white-cell and red-cell indices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GLQMixture, Control, White-Cell And Red-Cell IndicesHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000945000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000945000PARA 12 PLUS RETICSStreck Laboratories, Inc.2000-04-18GLQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740151270PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740151270003807401512703807401512700380740151270

GMDN Terms#

Term, Definition table
TermDefinition
Full blood count IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of 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, as well as other general blood evaluation tests [e.g., C-reactive protein (CRP)].

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
00380740151287AlinityAbbott GmbHGLQ2023-11-16
14987562460561e-CHECK(XS)SYSMEX CORPORATIONGLQ2017-10-06
20844509000321STaK-Chex Plus ReticsSTRECK, INC.GLQ2016-09-19
20844509000338STaK-Chex Plus ReticsSTRECK, INC.GLQ2016-09-19
20844509000345STaK-Chex Plus ReticsSTRECK, INC.GLQ2016-09-19
30844509000335STaK-Chex Plus ReticsSTRECK, INC.GLQ2016-09-19
00844509000358STaK-Chex Plus ReticsSTRECK, INC.GLQ2016-09-19
00844509000365STaK-Chex Plus ReticsSTRECK, INC.GLQ2016-09-19
20844509000253Cell-ChexSTRECK, INC.GLQ2016-09-16
20844509000260Cell-ChexSTRECK, INC.GLQ2016-09-16
20844509000277Cell-ChexSTRECK, INC.GLQ2016-09-16
30844509000267Cell-ChexSTRECK, INC.GLQ2016-09-16
00844509000280Cell-ChexSTRECK, INC.GLQ2016-09-16
00844509000297Cell-ChexSTRECK, INC.GLQ2016-09-16
00844509000303Cell-ChexSTRECK, INC.GLQ2016-09-16
30844509000618Para 12 ExtendSTRECK, INC.GLQ2016-09-14
30844509000625Para 12 ExtendSTRECK, INC.GLQ2016-09-14
30844509000632Para 12 ExtendSTRECK, INC.GLQ2016-09-14
40844509000615Para 12 ExtendSTRECK, INC.GLQ2016-09-14
40844509000622Para 12 ExtendSTRECK, INC.GLQ2016-09-14
40844509000639Para 12 ExtendSTRECK, INC.GLQ2016-09-14
50844509000612Para 12 ExtendSTRECK, INC.GLQ2016-09-14
00844509000648Para 12 ExtendSTRECK, INC.GLQ2016-09-14
00844509000655Para 12 ExtendSTRECK, INC.GLQ2016-09-14
00844509000662Para 12 ExtendSTRECK, INC.GLQ2016-09-14
00844509000679Para 12 ExtendSTRECK, INC.GLQ2016-09-14
00380740119829CELL-DYNABBOTT LABORATORIESGLQ2016-09-09
00380740119836CELL-DYNABBOTT LABORATORIESGLQ2016-09-09
14987562460288e-CHECKSYSMEX CORPORATIONGLQ2016-08-05
14987562460578e-CHECK(XS)SYSMEX CORPORATIONGLQ2016-08-05