FDA.reportPublic FDA data

RNA

Primary DI
00851290002355
Brand
RNA
Company
Rna Medical Division
Model
Glucose and B-ketone CVC
Catalog number
70906-01
Device description
Carton Label
Published
2017-12-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851290002355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851290002355008512900023558512900023550851290002355

GMDN Terms#

Term, Definition table
TermDefinition
Glucose/ketone/lipid profile IVD, controlA material which is used to verify the performance of a number of assays intended to be used together to produce a profile consisting of one or multiple clinical chemistry analytes which may include glucose, ketones and/or a lipid profile.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
101187037
Device count
1
Premarket 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
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
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