FDA.reportPublic FDA data

Cyto-Chex BCT

Primary DI
40844509002206
Brand
Cyto-Chex BCT
Company
STRECK, INC.
Model
230353
Catalog number
230353
Device description
A direct-draw blood collection tube for the preservation of whole blood specimens for immunophenotyping by flow cytometry. 4ml vials.
Published
2017-02-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GIMTubes, Vacuum Sample, With Anticoagulant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIMTubes, Vacuum Sample, With AnticoagulantClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080552000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080552000CYTO-CHEX BCTStreck2008-07-31GIM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40844509002206PrimaryGS10
00844509002208Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4084450900220640844509002206
00844509002208008445090022088445090022080844509002208

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, K3EDTAA sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the anticoagulant tripotassium ethylene diamine tetraacetic acid (K3EDTA). It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation [e.g., whole blood haematology such as complete blood count (CBC), and quantitative drug assay determinations]. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume4Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius30 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
1000
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
20192253050988MonojectCardinal Health 200, LLCGIM2026-05-05
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00850058457055BD MiniDraw Finger Sizing ToolBabson Diagnostics, Inc.GIM2025-12-09
00382903666171BD MiniDraw Finger Sizing ToolBabson Diagnostics, Inc.GIM2025-12-09
10197106953433CARDINAL HEALTHCardinal Health 200, LLCGIM2025-03-28
50197106953431CARDINAL HEALTHCardinal Health 200, LLCGIM2025-03-28
50192253051214CovidienCardinal Health 200, LLCGIM2025-01-14
10192253051216CovidienCardinal Health 200, LLCGIM2025-01-14
20192253051183MonojectCardinal Health 200, LLCGIM2024-10-08
50192253051184MonojectCardinal Health 200, LLCGIM2024-10-08
50382903666039BD MiniDraw™ H&H Capillary Blood Collection TubeBECTON, DICKINSON AND COMPANYGIM2024-06-06
50382903666138BD MiniDraw™ Finger Sleeve, SmallBECTON, DICKINSON AND COMPANYGIM2024-06-06
50382903666145BD MiniDraw™ Finger Sleeve, MediumBECTON, DICKINSON AND COMPANYGIM2024-06-06
50382903666152BD MiniDraw™ Finger Sleeve, LargeBECTON, DICKINSON AND COMPANYGIM2024-06-06
50382903666169BD MiniDraw™ Finger Sleeve, Extra-LargeBECTON, DICKINSON AND COMPANYGIM2024-06-06
50382903666176BD MiniDraw™ Finger Sizing ToolBECTON, DICKINSON AND COMPANYGIM2024-06-06
50382903666190BD MiniDraw™ Capillary Tube Adapter H&HBECTON, DICKINSON AND COMPANYGIM2024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, SmallBECTON, DICKINSON AND COMPANYGIM2024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, MediumBECTON, DICKINSON AND COMPANYGIM2024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, LargeBECTON, DICKINSON AND COMPANYGIM2024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-LargeBECTON, DICKINSON AND COMPANYGIM2024-06-06
30382903666172BD MiniDraw™ Finger Sizing ToolBECTON, DICKINSON AND COMPANYGIM2024-06-06
20192253050926MonojectCardinal Health 200, LLCGIM2024-02-28
20192253050940MonojectCardinal Health 200, LLCGIM2024-02-28
20192253050971MonojectCardinal Health 200, LLCGIM2024-02-28
20192253050995MonojectCardinal Health 200, LLCGIM2024-02-28
20192253051008MonojectCardinal Health 200, LLCGIM2024-02-28
20192253051015MonojectCardinal Health 200, LLCGIM2024-02-28
20192253051022MonojectCardinal Health 200, LLCGIM2024-02-28
20192253051039MonojectCardinal Health 200, LLCGIM2024-02-28