FDA.reportPublic FDA data

Streck Cell Preservative

Primary DI
10844509000850
Brand
Streck Cell Preservative
Company
STRECK, INC.
Model
213358
Catalog number
213358
Device description
An easy-to-use liquid preservative that maintains cellular antigen expression, including cluster of differentiation (CD) markers and cell morphology of biological samples for analysis by flow cytometry. Contains two (2) 10ml vials.
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LEAPreservative, Cytological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEAPreservative, CytologicalPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10844509000850PrimaryGS10
00844509000853Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084450900085010844509000850
00844509000853008445090008538445090008530844509000853

GMDN Terms#

Term, Definition table
TermDefinition
Lymphocyte stabilization reagent IVDA substance or reactant intended to be used for the stabilization, preservation and/or storage of lymphocytes following separation from a whole blood clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume10Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-800-228-6090custserv@streck.com

Regulatory Flags#

DUNS number
072915986
Device count
2
DM exempt
true
Premarket 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
10849832027819Leica BiosystemsLeica Biosystems Richmond, Inc.LEA2026-05-22
09551020410030PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410047PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410108PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410115PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410146PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410221PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410238PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410245PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410252PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410283PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410436PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410443PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410450PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410467PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410474PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410481PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410498PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
00613647028629FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEA2025-04-30
20613647028623FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEA2025-04-30
10849832002946Leica BiosystemsLeica Biosystems Richmond, Inc.LEA2024-12-27
00849832002949Leica BiosystemsLeica Biosystems Richmond, Inc.LEA2024-12-27
00810160180357SUPMEDICSupmedics Inc.LEA2024-11-04
00673693483032EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-10-22
00673693105279EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693105286EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693230858EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693230865EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693344692EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693344708EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04