FDA.report

Research and Diagnostic Systems

Primary DI
00815762020797
Brand
Research and Diagnostic Systems
Company
RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
Model
ST004
Catalog number
ST004
Device description
CBC-ST Plus: 6 x 2.5mL Vial TriPack (2 Low,2 Normal,2 High)
Published
2016-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JPKMixture, Hematology Quality Control

Product Code Classifications

CodeDeviceSpecialtyClass
JPKMixture, Hematology Quality ControlHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815762020797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815762020797008157620207978157620207970815762020797

GMDN Terms

TermDefinition
Full blood count IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of 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, as well as other general blood evaluation tests [e.g., C-reactive protein (CRP)].

Device Sizes

TypeValueUnit
Total Volume15Milliliter

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
800-428-4246customerserviceccd@bio-techne.com

Regulatory Flags

DUNS number
087248183
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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20815762020975Research and Diagnostic SystemsGH00LXGH00LX2016-07-29
20815762020999Research and Diagnostic SystemsGH00NXGH00NX2016-07-29
00815762020056Research and Diagnostic SystemsBF001BF0012016-08-03
00815762020063Research and Diagnostic SystemsBF002BF0022016-08-03
00815762020070Research and Diagnostic SystemsBFI001BFI0012016-08-03
00815762020087Research and Diagnostic SystemsBFI002BFI0022016-08-03

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