FDA.reportPublic FDA data

Albustix® Reagent Strips

Primary DI
00630414550602
Brand
Albustix® Reagent Strips
Company
Siemens Healthcare Diagnostics Inc.
Model
10333485
Catalog number
A2191B16
Device description
ALBUSTIX® are intended for in vitro diagnostic use by healthcare professionals to detect the presence of protein in urine.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CDMDIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
CENDYE-INDICATOR, PH (URINARY, NON-QUANT.)
JFYENZYMATIC METHOD, CREATININE
JILMETHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
JINNITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
JIOBLOOD, OCCULT, COLORIMETRIC, IN URINE
JIRINDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)
JJBAZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)
JMTDIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)
JREREFRACTOMETER FOR CLINICAL USE
LJXTEST, URINE LEUKOCYTE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)Clinical Chemistry1
CENDye-Indicator, Ph (Urinary, Non-Quantitative)Clinical Chemistry1
JFYEnzymatic Method, CreatinineClinical Chemistry2
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)Clinical Chemistry2
JINNitroprusside, Ketones (Urinary, Non-Quant.)Clinical Chemistry1
JIOBlood, Occult, Colorimetric, In UrineHematology2
JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)Clinical Chemistry1
JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)Clinical Chemistry1
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)Clinical Chemistry1
JRERefractometer For Clinical UseClinical Chemistry1
LJXTest, Urine LeukocyteHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992257000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992257000NEW MULTIPLES REAGENT STRIPSBayer Corp.1999-11-24JIR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414550602PrimaryGS10
00630414009650Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414550602006304145506026304145506020630414550602
00630414009650006304140096506304140096500630414009650

GMDN Terms#

Term, Definition table
TermDefinition
Urine protein IVD, kit, colorimetric dipstick, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative screening of urine for protein within a short period relative to standard laboratory testing procedures, using a colorimetric dipstick method. This test is commonly used in the laboratory or in point-of-care analyses.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not store in direct sunlight.
Storage Environment Temperature15 Degrees Celsius30 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
100
Lot or batch
true
Expiration date on label
true

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00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
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