AccessGUDID - DEVICE: Azostix® Reagent Strips (00630414551142)

GUDID

Device Identifier (DI) Information

Brand Name: Azostix® Reagent Strips
Version or Model: 10324060
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A2830C16
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414551142
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: AZOSTIX® is a firm, plastic strip to which is affixed an impregnated reagent area for estimating the amount of urea nitrogen in whole blood to provide information on renal function.

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?
53587	Urea IVD, kit, enzyme spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen, using an enzyme spectrophotometry method. It is typically used as an indicator of kidney function and/or to differentiate between prerenal and postrenal azotemia.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JMT	DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)
JFY	ENZYMATIC METHOD, CREATININE
JIL	METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
CDM	DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
LJX	TEST, URINE LEUKOCYTE
JIN	NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
JIR	INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)
CEN	DYE-INDICATOR, PH (URINARY, NON-QUANT.)
JIO	BLOOD, OCCULT, COLORIMETRIC, IN URINE
JRE	REFRACTOMETER FOR CLINICAL USE
JJB	AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (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: 62a97647-281a-4f37-9fc0-22e1e91e5c41
Public Version Date: November 19, 2021
Public Version Number: 6
DI Record Publish Date: September 24, 2016