FDA.reportPublic FDA data

CD-Chex CD34

Primary DI
20844509000475
Brand
CD-Chex CD34
Company
STRECK, INC.
Model
213346
Catalog number
213346
Device description
A positive procedural control for enumerating CD34 positive cells by flow cytometry. Contains 1 vial of level 2.
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
GGLControl, White-Cell

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGLControl, White-CellHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993126000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993126000CD-CHEX CD 34Streck Laboratories, Inc.1999-11-26GGL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20844509000475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084450900047520844509000475

GMDN Terms#

Term, Definition table
TermDefinition
Multiple CD cell marker IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple cluster of differentiation (CD) cell markers in a clinical specimen, including associated percentage and/or enumeration of specific cell populations.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Milliliter

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
40844509000134CD-Chex PlusSTRECK, INC.GGL2016-12-01
40844509000141CD-Chex PlusSTRECK, INC.GGL2016-12-01
15099590541972CYTO-TROL CONTROL CELLSBeckman Coulter, Inc.GGL2016-09-23
10844509000089CD-Chex PlusSTRECK, INC.GGL2016-09-16
10844509000096CD-Chex PlusSTRECK, INC.GGL2016-09-16
20844509000086CD-Chex PlusSTRECK, INC.GGL2016-09-16
20844509000093CD-Chex PlusSTRECK, INC.GGL2016-09-16
20844509000130CD-Chex PlusSTRECK, INC.GGL2016-09-16
20844509000147CD-Chex PlusSTRECK, INC.GGL2016-09-16
20844509000468CD-Chex CD34STRECK, INC.GGL2016-09-16
20844509000482CD-Chex CD34STRECK, INC.GGL2016-09-16
20844509000512CD-Chex Plus BCSTRECK, INC.GGL2016-09-16
20844509000529CD-Chex Plus BCSTRECK, INC.GGL2016-09-16
30844509000083CD-Chex PlusSTRECK, INC.GGL2016-09-16
30844509000090CD-Chex PlusSTRECK, INC.GGL2016-09-16
30844509000137CD-Chex PlusSTRECK, INC.GGL2016-09-16
30844509000144CD-Chex PlusSTRECK, INC.GGL2016-09-16
30844509000465CD-Chex CD34STRECK, INC.GGL2016-09-16
30844509000472CD-Chex CD34STRECK, INC.GGL2016-09-16
30844509000489CD-Chex CD34STRECK, INC.GGL2016-09-16
30844509000519CD-Chex Plus BCSTRECK, INC.GGL2016-09-16
30844509000526CD-Chex Plus BCSTRECK, INC.GGL2016-09-16
40844509000080CD-Chex PlusSTRECK, INC.GGL2016-09-16
40844509000516CD-Chex Plus BCSTRECK, INC.GGL2016-09-16
40844509000523CD-Chex Plus BCSTRECK, INC.GGL2016-09-16
00844509000105CD-Chex PlusSTRECK, INC.GGL2016-09-16
00844509000112CD-Chex PlusSTRECK, INC.GGL2016-09-16
00844509000129CD-Chex PlusSTRECK, INC.GGL2016-09-16
00844509000150CD-Chex PlusSTRECK, INC.GGL2016-09-16
00844509000167CD-Chex PlusSTRECK, INC.GGL2016-09-16