Cell-Chex

Primary DI
00844509000280
Brand
Cell-Chex
Company
STRECK, INC.
Model
212420
Catalog number
212420
Device description
Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC) counts, crystal identification, and white blood cell differentiation. Contains 2 vials each of L1-UC and L2.
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K101335000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101335000CELL-CHEXStreck2010-08-23GLQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844509000280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844509000280008445090002808445090002800844509000280

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)].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume2Milliliter

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
1-800-228-6090custserv@streck.com

Regulatory Flags#

DUNS number
072915986
Device count
1
DM 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
20844509000314Cal-Chex A Plus 2211062211062016-09-16
30844509000311Cal-Chex A Plus 2211072211072016-09-16
40844509000318Cal-Chex A Plus2211082211082016-09-16
20844509000338STaK-Chex Plus Retics2254812254812016-09-19
00844509001379CVA2915042915042016-09-16
00844509001386CVA2917082917082016-09-16
00844509001393CVA2917092917092016-09-16
00844509001409CVA2917102917102016-09-16
00844509001416CVA2917112917112016-09-16
00844509001423CVA2917122917122016-09-16
00844509001430CVA2917132917132016-09-16
00844509001447CVA2917142917142016-09-16
00844509001560CVA for CellDyn 2917152917152016-09-16
00844509001577CVA for CellDyn 2917182917182016-09-16
00844509001584CVA for CellDyn 2917192917192016-09-16
00844509001591CVA for CellDyn 2917202917202016-09-16
00844509001669CVA2917222917222016-09-16
20844509000246Cal-Chex2211012211012016-09-16
30844509000243Cal-Chex 2211032211032016-09-16
10844509000089CD-Chex Plus2133252133252016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740151270AlinityAbbott GmbHGLQ2023-11-16
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
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