AccessGUDID - DEVICE: One+Step 10A (08806141303497)

GUDID

Device Identifier (DI) Information

Brand Name: One+Step 10A
Version or Model: 30D4
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: DFI CO.,LTD

Primary DI Number: 08806141303497
Issuing Agency: GS1
Commercial Distribution End Date: October 16, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 688779180 *Terms of Use

Device Description: One device is included 100 test strips

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:	Yes
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?
54514	Multiple urine analyte IVD, kit, rapid colorimetric, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple analytes 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 to screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins]. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LJX	Test, Urine Leukocyte
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)
JRE	Refractometer For Clinical Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ee216bc5-512b-4dcc-83bf-7360a40b6deb
Public Version Date: October 24, 2023
Public Version Number: 1
DI Record Publish Date: October 16, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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