CELL-DYN

Primary DI
00380740119829
Brand
CELL-DYN
Company
ABBOTT LABORATORIES
Model
09H72-01
Catalog number
09H7201
Device description
CELL-DYN 22 Plus Control
Published
2016-09-09
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
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
K111211000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111211000CELL-DYN 22 PLUS CONTROLStreck2011-12-22GLQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740119829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740119829003807401198293807401198290380740119829

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
079226220
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740202798Alinity04W560704W56072025-07-21
00380740203108Alinity04W561504W56152025-07-21
00380740203115Alinity04W562504W56252025-07-21
00380740203139Alinity04W566104W56612025-07-21
00380740192402CELL-DYN09H600309H60032020-12-18
00380740020132CELL-DYN09H46-0209H46022016-06-06
00380740020149CELL-DYN09H47-0209H47022016-06-06
00380740020156CELL-DYN09H48-0209H48022016-06-06
00380740120771CELL-DYN09H610109H61012016-09-09
00380740120788CELL-DYN09H62-0109H62012016-09-09
00380740202668Alinity06P010706P01072025-10-03
00380740202828Alinity06P011506P01152025-10-03
00380740202835Alinity06P012506P01252025-10-03
00380740202859Alinity06P016106P01612025-10-03
00380740202996Alinity06P080706P08072025-09-17
00380740203023Alinity06P081506P08152025-09-17
00380740203030Alinity06P082506P08252025-09-17
00380740203054Alinity06P086106P08612025-09-17
00380740196257GLP systems Track04Z965104Z96512023-08-30
00380740225186ARCHITECT04P553004P55302026-05-14

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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
00380740119836CELL-DYNABBOTT LABORATORIESGLQ2016-09-09
14987562460288e-CHECKSYSMEX CORPORATIONGLQ2016-08-05
14987562460578e-CHECK(XS)SYSMEX CORPORATIONGLQ2016-08-05