FDA.reportPublic FDA data

DCA 2000® Microalbumin Creatinine control kit

Primary DI
00630414535722
Brand
DCA 2000® Microalbumin Creatinine control kit
Company
Siemens Healthcare Diagnostics Inc.
Model
10325406
Catalog number
6012A
Device description
The DCA Microalbumin Creatinine Control Kit contains both Low Controls and High Controls. Each control is a buffered aqueous solution containing known amounts of human albumin and creatinine. The resulting mixture is then lyophilized to ensure stability. The DCA Microalbumin Creatinine Control Kit has been designed for use with the DCA Microalbumin Creatinine Reagent Kit.
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
JIRINDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K963142000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963142000DCA 2000 + MICROALBUMIN/CREATININE ASSAYBayer Corp.1996-09-27JIR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414535722PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414535722006304145357226304145357220630414535722

GMDN Terms#

Term, Definition table
TermDefinition
Microalbumin IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of microalbumin 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(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
1
Lot or batch
true
Expiration date on label
true

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00630414611075Atellica CH Crea311537215115372152026-05-08
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00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08

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