FDA.reportPublic FDA data

Abbott mSample Preparation System RNA Bulk Lysis Buffer Kit

Primary DI
00849811004636
Brand
Abbott mSample Preparation System RNA Bulk Lysis Buffer Kit
Company
PROMEGA CORPORATION
Model
02N77-01
Catalog number
02N77-01
Device description
Lysis buffer used to lyse cells for nucleic acid extraction.
Published
2017-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PPMGeneral Purpose Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849811004636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849811004636008498110046368498110046360849811004636

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid extraction/isolation kit IVDA collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)553-7042customerservice@abbottmolecular.com

Regulatory Flags#

DUNS number
089855696
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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00849811031717OncoMate MSI Dx Analysis SystemMD2140MD21402021-09-30
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00849811066115Maxwell® CSC Genomic DNA KitAS1850AS18502023-06-12
00849811060960Maxwell® CSC Viral Total Nucleic Acid Purification Kit AS1780AS17802022-02-01
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00849811051739Maxwell® CSC RNA Blood KitAS1410AS14102022-02-01
00849811051746Maxwell® CSC RNA FFPE KitAS1360AS13602022-02-01
00849811051753Maxwell® CSC DNA FFPE KitAS1350AS13502022-02-01
00849811051777Maxwell® CSC Blood DNA KitAS1321AS13212022-02-01
00849811056857OncoMate MSI Dx Interpretive SoftwareMD4140MD41402021-10-08
00849811056864OncoMate MSI Dx Assay InstallerMD4150MD41502021-10-08
00849811004445Abbott mSample Preparation System04J70-2404J70-242017-08-25

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