FDA.reportPublic FDA data

RNA

Primary DI
10851290002376
Brand
RNA
Company
Rna Medical Division
Model
QC 823 Level 1
Catalog number
QC 823-1
Device description
Carton for QC 823 Level 1
Published
2019-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851290002376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085129000237610851290002376

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood gas/haemoximetry/electrolyte analyte IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).

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
10851290002550RNA MedicalCVC 123 CVC 1232020-08-11
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
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