FDA.reportPublic FDA data

Para 12 Plus

Primary DI
00844509000211
Brand
Para 12 Plus
Company
STRECK, INC.
Model
218903
Catalog number
218903
Device description
A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differential instruments. Contains 1 vial each of low, normal and high levels.
Published
2016-09-14
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
JCNControl, Cell Counter, Normal And Abnormal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCNControl, Cell Counter, Normal And AbnormalHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K901875000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K901875000PARA 12 PLUSStreck Laboratories, Inc.1990-05-30JCN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844509000211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844509000211008445090002118445090002110844509000211

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 Volume3Milliliter

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
00815762020490Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JCN2025-12-01
30844509000199Para 12® PlusSTRECK, INC.JCN2020-08-24
B787OCK10OLO Control KitS.D. SIGHT DIAGNOSTICS LTDJCN2020-05-04
00815762021978R & D Systems, Inc. CBC-PIX Hematology ControlRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JCN2018-12-05
00630414224367ADVIA® 120/2120/2120i TESTpoint Low ControlSiemens Healthcare Diagnostics Inc.JCN2016-09-24
00630414224381ADVIA® 120/2120/2120i TESTpoint Normal ControlSiemens Healthcare Diagnostics Inc.JCN2016-09-24
00630414224404ADVIA® 120/2120/2120i TESTpoint High ControlSiemens Healthcare Diagnostics Inc.JCN2016-09-24
00630414473390ADVIA® 120/2120/2120i 3-in-1 TESTpoint Normal ControlSiemens Healthcare Diagnostics Inc.JCN2016-09-24
00630414473406ADVIA® 120/2120/2120i 3-in-1 TESTpoint Low ControlSiemens Healthcare Diagnostics Inc.JCN2016-09-24
00630414473413ADVIA® 120/2120/2120i 3-in-1 TESTpoint High ControlSiemens Healthcare Diagnostics Inc.JCN2016-09-24
20844509001144STaK-ChexSTRECK, INC.JCN2016-09-19
20844509001151STaK-ChexSTRECK, INC.JCN2016-09-19
20844509001168STaK-ChexSTRECK, INC.JCN2016-09-19
30844509001158STaK-ChexSTRECK, INC.JCN2016-09-19
00844509001171STaK-ChexSTRECK, INC.JCN2016-09-19
00844509001188STaK-ChexSTRECK, INC.JCN2016-09-19
20844509000185Para 12 PlusSTRECK, INC.JCN2016-09-14
20844509000192Para 12 PlusSTRECK, INC.JCN2016-09-14
20844509000208Para 12 PlusSTRECK, INC.JCN2016-09-14
00844509000228Para 12 PlusSTRECK, INC.JCN2016-09-14
00844509000235Para 12 PlusSTRECK, INC.JCN2016-09-14
00847661002963LiquichekBIO-RAD LABORATORIES, INC.JCN2016-09-12
00847661002970LiquichekBIO-RAD LABORATORIES, INC.JCN2016-09-12
00847661002987LiquichekBIO-RAD LABORATORIES, INC.JCN2016-09-12
00847661002994LiquichekBIO-RAD LABORATORIES, INC.JCN2016-09-12
00847661003007LiquichekBIO-RAD LABORATORIES, INC.JCN2016-09-12
00380740017101CELL-DYNABBOTT LABORATORIESJCN2016-06-06
00380740017118CELL-DYNABBOTT LABORATORIESJCN2016-06-06