RNARetain

Primary DI
00863840000285
Brand
RNARetain
Company
ASURAGEN, INC.
Model
84001
Catalog number
84001
Published
2019-11-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OZFTissue Rna Preservative For Collection, Storage, And Transportation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZFTissue Rna Preservative For Collection, Storage, And TransportationImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113420000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113420000RNARETAINAsuragen, Inc.2012-03-16OZF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863840000285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863840000285008638400002858638400002850863840000285

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, preservation solution, non-sterileA non-sterile covered plastic receptacle containing a preservative (e.g., cell or nucleic acid preservation solution) intended to be used for the collection, and preservation and/or transport, of any type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) collected from any body part for in vitro diagnostic procedures [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
622988330
Device count
1
Lot or batch
true

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