FDA.reportPublic FDA data

Dimension® Flex® reagent cartridge PCHE

Primary DI
00842768014178
Brand
Dimension® Flex® reagent cartridge PCHE
Company
Siemens Healthcare Diagnostics Inc.
Model
10444964
Catalog number
DF51
Device description
Pseudocholinesterase Flex® reagent cartridge, 120 tests
Published
2020-09-24
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
DIHColorimetry, cholinesterase
DLIAcetylcholine chloride, specific reagent for pseudo cholinesterase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIHColorimetry, CholinesteraseClinical Toxicology1
DLIAcetylcholine Chloride, Specific Reagent For Pseudo CholinesteraseClinical Toxicology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K950180000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K950180000DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHODE.I. Dupont DE Nemours & Co., Inc.1995-03-15DLI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768014178PrimaryGS10
00630414004464Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768014178008427680141788427680141780842768014178
00630414004464006304140044646304140044640630414004464

GMDN Terms#

Term, Definition table
TermDefinition
Pseudocholinesterase IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of the enzyme pseudocholinesterase in a clinical specimen, using an enzyme spectrophotoometry 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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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