FDA.reportPublic FDA data

Research and Diagnostic Systems

Primary DI
10815762021371
Brand
Research and Diagnostic Systems
Company
RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
Model
SR0012
Catalog number
SR0012
Device description
SedRite Plus: 8 x 9mL (Level 2)
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
JPKMixture, Hematology Quality Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPKMixture, Hematology Quality ControlHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991876000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991876000SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATER&D Systems, Inc.1999-06-17JPK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815762021371PrimaryGS10
00815762021374Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081576202137110815762021371
00815762021374008157620213748157620213740815762021374

GMDN Terms#

Term, Definition table
TermDefinition
Erythrocyte sedimentation rate (ESR) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative determination of erythrocyte sedimentation rate (ESR) of a whole blood clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume72Milliliter

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
8
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
00860015924209ST 201 Fetal Hemoglobin ControlSURE-TECH DIAGNOSTIC ASSOCIATES, INC.JPK2026-05-19
00860015924216ST 201-B Fetal Hemoglobin ControlSURE-TECH DIAGNOSTIC ASSOCIATES, INC.JPK2026-05-19
00860015924223ST 201-C Fetal Hemoglobin ControlSURE-TECH DIAGNOSTIC ASSOCIATES, INC.JPK2026-05-19
00630414290058Atellica HEMA Control (L)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290065Atellica HEMA Control (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290072Atellica HEMA Control (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290089Atellica HEMA Retic Control (L)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290096Atellica HEMA Retic Control (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290102Atellica HEMA Retic Control (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290119Atellica HEMA Control BF (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290126Atellica HEMA Control BF (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323640Atellica HEMA Control (L)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323657Atellica HEMA Control (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323534Atellica HEMA Control (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323541Atellica HEMA Retic Control (L)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323558Atellica HEMA Retic Control (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323565Atellica HEMA Retic Control (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323572Atellica HEMA Control BF (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323589Atellica HEMA Control BF (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00860001900538IntelliSep Quality Control KitCytovale IncJPK2025-07-03
00815762026362Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JPK2025-06-06
00815762026508Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JPK2025-06-04
03610230008584BFTROLHORIBA ABX SASJPK2024-09-26
03610230009581ABX Minotrol 16HORIBA ABX SASJPK2024-09-25
03610230009598ABX Minotrol 16HORIBA ABX SASJPK2024-09-25
03610230009604ABX Minotrol 16HORIBA ABX SASJPK2024-09-25
00868556000215HemaTechnologies ESR ControlAirscan, Inc.JPK2024-06-04
00868556000239HemaTechnologies ESR ControlAirscan, Inc.JPK2024-06-04
00868556000246HemaTechnologies ESR ControlAirscan, Inc.JPK2024-06-04
00868556000253HemaTechnologies ESR ControlAirscan, Inc.JPK2024-06-04