FDA.reportPublic FDA data

Research and Diagnostic Systems

Primary DI
10815762021609
Brand
Research and Diagnostic Systems
Company
RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
Model
TCV11
Catalog number
TCV11
Device description
Tech-Cal: 2 x 3.5mL Whole Blood Calibrator
Published
2016-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KSACalibrator For Red-Cell And White-Cell Counting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSACalibrator For Red-Cell And White-Cell CountingHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K881161000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K881161000TECH-CAL(TM)/MULTIPLER&D Systems, Inc.1988-05-02KSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815762021609PrimaryGS10
00815762021602Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081576202160910815762021609
00815762021602008157620216028157620216020815762021602

GMDN Terms#

Term, Definition table
TermDefinition
Full blood count IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of one or 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume7Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
800-428-4246customerserviceccd@bio-techne.com

Regulatory Flags#

DUNS number
087248183
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815762021183Research and Diagnostic SystemsPTE004PTE0042016-07-29
00815762021923Research and Diagnostic SystemsPTE5XPTE5X2016-09-13
00815762021930Research and Diagnostic SystemsPTE4XPTE4X2016-09-13
00815762021947Research and Diagnostic SystemsPTE6XPTE6X2016-09-13
00815762021954Research and Diagnostic SystemsPTE3XPTE3X2016-09-13
00815762021190Research and Diagnostic SystemsPTE006PTE0062016-07-29
00815762020490Research and Diagnostic SystemsPIX0022025-12-01
00815762023446Research and Diagnostic Systems0CP010TA32025-12-01
00815762023453Research and Diagnostic Systems0CP020TA32025-12-01
00815762021657Research and Diagnostic SystemsDTFR1DTFR12016-07-29
00815762021718Research and Diagnostic SystemsRDKAP1971RDKAP19712016-09-01
00815762021978R & D Systems, Inc. CBC-PIX Hematology ControlP0022018-12-05
00815762020131Research and Diagnostic Systems3D5043D5042016-12-20
00815762020148Research and Diagnostic Systems3D5053D5052016-12-20
00815762020155Research and Diagnostic Systems3D505T3D505T2016-12-20
00815762020223Research and Diagnostic Systems3D5183D5182016-12-20
00815762021145Research and Diagnostic SystemsLH002LH0022016-07-29
00815762021152Research and Diagnostic SystemsLH004LH0042016-07-29
00815762021282Research and Diagnostic SystemsRP401RP4012016-07-29
00815762021299Research and Diagnostic SystemsRP403RP4032016-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414287201Atellica HEMA CalibratorSiemens Healthcare Diagnostics Inc.KSA2026-02-06
03610230009611ABX MinocalHORIBA ABX SASKSA2024-09-27
00380740151294AlinityAbbott GmbHKSA2023-11-16
20844509000314Cal-Chex A Plus STRECK, INC.KSA2016-09-16
30844509000311Cal-Chex A Plus STRECK, INC.KSA2016-09-16
40844509000318Cal-Chex A PlusSTRECK, INC.KSA2016-09-16
14987562460370SCS-1000 CalibratorSYSMEX CORPORATIONKSA2016-08-04
00380740017071CELL-DYNABBOTT LABORATORIESKSA2016-06-06