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Dimension® ACP Verifier

Primary DI
00842768005039
Brand
Dimension® ACP Verifier
Company
Siemens Healthcare Diagnostics Inc.
Model
10444994
Catalog number
DC23
Device description
Acid Phosphatase Verifier, 2x3x1mL, volume after reconstituted
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
CKEAcid phosphatase, thymolphthale inmonophosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CKEAcid Phosphatase, Thymolphthale InmonophosphateClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K864230000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K864230000DIMENSION (TM) CLINICAL CHEMISTRY SYSTEME.I. Dupont DE Nemours & Co., Inc.1986-11-28CKE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768005039PrimaryGS10
00630414017020Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768005039008427680050398427680050390842768005039
00630414017020006304140170206304140170200630414017020

GMDN Terms#

Term, Definition table
TermDefinition
Acid phosphatase isoenzyme 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 one or multiple acid phosphatase isoenzymes in a clinical specimen.

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
6
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00630414508399ADVIA® Chemistry IP Inorganic Phosphorus Reagents10309503103095032020-09-24
00630414508429ADVIA® Chemistry MG Magnesium Reagents10309506103095062020-09-24
00630414561073ADVIA® Chemistry CHOL_2 Cholesterol_2 Reagent10376501103765012020-09-24
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00842768013836Dimension Cardiac Troponin-I Flex reagent cartridge10444905104449052016-09-24
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00630414008967ADVIA® Chemistry Enzyme 1 Calibrator10916057109160572016-09-24
00630414177328ADVIA Centaur® AFP10309979103099792014-09-24
00630414553153ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated10283343102833432016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842768005275Dimension® Flex® reagent cartridge ACPSiemens Healthcare Diagnostics Inc.CKE2016-09-24