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cobas&#x00AE MPX Control Kit

Primary DI
00875197004847
Brand
cobas&#x00AE MPX Control Kit
Company
Roche Diagnostics GmbH
Model
06999069190
Catalog number
06999069190
Published
2017-02-14
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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00875197004847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00875197004847008751970048478751970048470875197004847

GMDN Terms

TermDefinition
HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of human immunodeficiency virus 1 (HIV1) nucleic acid, Hepatitis C virus nucleic acid and/or Hepatitis B virus nucleic acid in a clinical specimen.

Sterilization Methods

Method

Regulatory Flags

DUNS number
315028860
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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