FDA.report

ONLINE DAT Benzodiazepines II

Primary DI
07613336121054
Brand
ONLINE DAT Benzodiazepines II
Company
Roche Diagnostics GmbH
Model
08056927190
Catalog number
08056927190
Published
2023-05-11
Public version status
New
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

Product Codes

CodeName
JXMEnzyme immunoassay, benzodiazepine

Product Code Classifications

CodeDeviceSpecialtyClass
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2

Premarket Submissions

SubmissionSupplement
K221765000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K221765000ONLINE DAT Benzodiazepines IIRoche Diagnostics2022-12-23JXM

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613336121054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613336121054076133361210547613336121054

GMDN Terms

TermDefinition
Benzodiazepine group IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple benzodiazepines 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
false
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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04015630911707Elecsys Myoglobin STAT CalSet11820893122118208931222016-09-20
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04015630919932C.f.a.s. PAC3555941190035559411902016-09-20
04015630936373Cfas Proteins11355279160113552791602016-09-20
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04015630940073Elecsys BRAHMS PCT07301715190073017151902017-04-21
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07613336232132Ionify Steroids 209634444160096344441602025-12-11
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07613336216965PreciControl Phospho-Tau (181P) Plasma09697926190096979261902025-11-18
07613336231357cobas i 601 SBL10271574001102715740012025-08-08

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