FDA.reportPublic FDA data

CYTO-TROL CONTROL CELLS

Primary DI
15099590541972
Brand
CYTO-TROL CONTROL CELLS
Company
Beckman Coulter, Inc.
Model
6604248
Catalog number
6604248
Device description
COULTER CYTO-TROL Control Cells Kit
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K894651000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K894651000COULTER POSITIVE CONTROL CELLSCoulter Corp.1989-09-13GGL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590541972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959054197215099590541972

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590807696UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)D30863D308632026-05-19
15099590806323Access anti-HBc IgM D22920D229202026-05-04
15099590806330Access anti-HBc IgM CalibratorD22921D229212026-05-04
15099590806347Access anti-HBc IgM QCD22922D229222026-05-04
15099590806446Access anti-HAV IgMD25834D258342026-04-23
15099590806453Access anti-HAV IgM CalibratorD25835D258352026-04-23
15099590806460Access anti-HAV IgM QCD25836D258362026-04-23
15099590233501Synchron4725004725002016-08-24
15099590786533Access BNP IID06227D062272026-03-30
15099590806293Hepatitis B Virus core Total AntibodyD22917D229172026-03-30
15099590806309ACCESS anti-HBc Total CALIBRATORD22918D229182026-03-30
15099590806316ACCESS anti-HBc Total QCD22919D229192026-03-30
15099590572822Cytomics FC500UPS (MPL)6265542016-09-23
15099590572839Cytomics FC500UPS (CXP)6265532016-09-23
15099590736002Access PCTC53987C539872023-05-05
15099590806255ACCESS HBsAgD229132026-01-16
15099590806262ACCESS HBsAg ConfirmatoryD229142026-01-16
15099590806279Access HBsAg CALIBRATORD229152026-01-16
15099590806286ACCESS HBsAg QCD229162026-01-16
15099590806415ACCESS anti-HAVD258312026-01-16

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
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
20844509000475CD-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