FDA.reportPublic FDA data

Dimension® Flex® reagent cartridge PHNO

Primary DI
00842768005596
Brand
Dimension® Flex® reagent cartridge PHNO
Company
Siemens Healthcare Diagnostics Inc.
Model
10444933
Catalog number
DF60
Device description
Phenobarbital Flex® reagent cartridge, 80 tests
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DLZENZYME IMMUNOASSAY, PHENOBARBITAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DLZEnzyme Immunoassay, PhenobarbitalClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K944932000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K944932000PHENOBARBITAL FLEX REAGENT CARTRIDGEDupont Medical Products1994-12-28DLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768005596PrimaryGS10
00630414004181Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768005596008427680055968427680055960842768005596
00630414004181006304140041816304140041810630414004181

GMDN Terms#

Term, Definition table
TermDefinition
Phenobarbital IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of phenobarbital 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

Contacts#

Phone, Email table
PhoneEmail
+1(800)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
4
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
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00630414595993Atellica CH PhnbSiemens Healthcare Diagnostics Inc.DLZ2017-12-22
05055273206401PHBRANDOX LABORATORIES LIMITEDDLZ2016-09-24
00842768015397Dimension Vista® Flex® reagent cartridge PHNOSiemens Healthcare Diagnostics Inc.DLZ2016-09-24
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00842768023224Emit® 2000 Phenobarbital AssaySiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00630414527192ADVIA Centaur® PHNBSiemens Healthcare Diagnostics Inc.DLZ2016-09-24
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00380740001773ARCHITECTABBOTT LABORATORIESDLZ2016-06-06
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