FDA.reportPublic FDA data

RNA Medical

Primary DI
10851290002550
Brand
RNA Medical
Company
Rna Medical Division
Model
CVC 123
Catalog number
CVC 123
Device description
Carton for CVC 123
Published
2020-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JJYMulti-Analyte Controls, All Kinds (Assayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K943754000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K943754000BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCTBionostics, Inc.1994-09-14JJY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851290002550PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085129000255010851290002550

GMDN Terms#

Term, Definition table
TermDefinition
Flow cytometer calibration/verification solution IVDA solution containing beads or particles with known optical and physical characteristics (e.g., antibodies conjugated with fluorescent dyes, specified size or other label) intended to be used to verify and/or optimize the performance of a flow cytometer or similar single/multichannel instrument. Verification/optimization functions may include optical density (absorbance), fluorescent or luminescent accuracy and compensation, linearity, repeatability, sensitivity, limit of detection and/or light scatter readings at specified wavelengths, and the ability to verify optical alignment and precision of the instrument or analyser. Solutions are typically single-use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
101187037
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10851290002567RNA MedicalCVC 223CVC 2232022-07-25
10851290002437RNACC527 Level 3CC 527-32019-10-29
10851290002499RNAQC 623 Level 1QC 623-12019-10-29
10851290002505RNAQC 623 Level 2QC 623-22019-10-29
10851290002512RNAQC 623 level 3QC 623-32019-10-29
10851290002529RNAQC 623 Level 4QC 623-42019-10-29
10851290002536RNAQC 623 Multi-LevelQC 6232019-10-29
10851290002543RNAQC 463 Multi-LevelQC 4632019-10-29
10851290002376RNAQC 823 Level 1QC 823-12019-06-03
10851290002383RNAQC 823 Level 2QC 823-22019-06-03
10851290002390RNAQC 823 Level 3QC 823-32019-06-03
10851290002406RNAQC 823 Multi LevelQC 8232019-06-03
10851290002413RNACC527 Level 1CC 527-12019-06-03
10851290002420RNACC527 Level 2CC 527-22019-06-03
10851290002444RNACC527 Multi-LevelCC 5272019-06-03
10851290002451RNA QC 253 Level 1QC 253-12019-06-03
10851290002468RNAQC 253 Level 2QC 253-22019-06-03
10851290002475RNAQC 253 Level 3QC 253-32019-06-03
10851290002482RNAQC 253 Multi-LevelQC 2532019-06-03
00851290002010RNACT 095CT 0952019-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884883009080MAS Immunology Advanced Sample PackMicrogenics CorporationJJY2026-05-27
00884883011373MAS Immunology Advanced Level 1Microgenics CorporationJJY2026-05-27
00884883011380MAS Immunology Advanced Level 2Microgenics CorporationJJY2026-05-27
00884883011397MAS Immunology Advanced Level 3Microgenics CorporationJJY2026-05-27
00884883011427CRP (C-Reactive Protein)Microgenics CorporationJJY2026-05-27
00850028489048TriVerity Level 1 Quality ControlInflammatix, Inc.JJY2026-04-30
00850028489055TriVerity Level 2 Quality ControlInflammatix, Inc.JJY2026-04-30
00850028489093TriVerity Verification PanelInflammatix, Inc.JJY2026-04-30
00850028489109TriVerity Mini Verification PanelInflammatix, Inc.JJY2026-04-30
00850011135747VALIDATELgc Clinical Diagnostics, Inc.JJY2026-04-24
00850075957330KOVA-Trol II Low AbnormalLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957378KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957385KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957392KOVA-Trol I High Abnormal With Urobilinogen Lgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957408KOVA-Trol I High Abnormal With Urobilinogen Lgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957415KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957439KOVA-Trol I High Abnormal with Urobilinogen Value AssignmentLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850011135822VALIDATELgc Clinical Diagnostics, Inc.JJY2025-10-08
00850011135839VALIDATELgc Clinical Diagnostics, Inc.JJY2025-10-08
00850011135716ValidateLgc Clinical Diagnostics, Inc.JJY2024-09-05
00852676007087Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJY2023-08-09
00852676007094Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJY2023-08-09
00852676007100Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJY2023-08-09
03610522248377LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248384LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248391LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248407LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248667LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248674LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248681LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31