FDA.reportPublic FDA data

Theophylline

Primary DI
04015630997787
Brand
Theophylline
Company
Roche Diagnostics GmbH
Model
4491025190
Catalog number
4491025190
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LGSFLUORESCENCE POLARIZATION IMMUNOASSAY, THEOPHYLLINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGSFluorescence Polarization Immunoassay, TheophyllineClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951595000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951595000ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTESRoche Diagnostic Systems, Inc.1995-09-08CGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630997787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630997787040156309977874015630997787

GMDN Terms#

Term, Definition table
TermDefinition
Theophylline therapeutic drug monitoring IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the anti-asthma drug theophylline in a clinical specimen, using a nephelometry/turbidimetry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740155940ARCHITECTAbbott GmbHLGS2020-03-03
04015630915910TheophyllineRoche Diagnostics GmbHLGS2016-09-20
00380740001698ARCHITECTAbbott GmbHLGS2016-06-06
00380740001704ARCHITECTAbbott GmbHLGS2016-06-06