AccessGUDID - DEVICE: Albustix® Reagent Strips (00630414550602)

GUDID

Device Identifier (DI) Information

Brand Name: Albustix® Reagent Strips
Version or Model: 10333485
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A2191B16
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414550602
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: ALBUSTIX® are intended for in vitro diagnostic use by healthcare professionals to detect the presence of protein in urine.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
54523	Urine protein IVD, kit, rapid colorimetric, clinical	A 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 rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIL	METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
JIN	NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
JRE	REFRACTOMETER FOR CLINICAL USE
JMT	DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)
JIO	BLOOD, OCCULT, COLORIMETRIC, IN URINE
CDM	DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
JIR	INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)
JJB	AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)
JFY	ENZYMATIC METHOD, CREATININE
LJX	TEST, URINE LEUKOCYTE
CEN	DYE-INDICATOR, PH (URINARY, NON-QUANT.)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K992257	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Do not store in direct sunlight.
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 819ef18f-3813-4a41-b439-2576db12c4ad
Public Version Date: November 28, 2022
Public Version Number: 6
DI Record Publish Date: September 24, 2016