DEVICE: Rapid Response (00722066001219)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
Rapid Response
UA-500
In Commercial Distribution

BTNX Inc
00722066001219
GS1

1
251005005 *Terms of Use
Urine Analyzer 500
CLOSE

Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
57861 Urine analyser IVD, point-of-care
A mains electricity (AC-powered) instrument intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KQO Automated Urinalysis System
NGJ Test, Nitrite, Urinary, Non-Quantitative, Over The Counter
LJX Test, Urine Leukocyte
JRE Refractometer For Clinical Use
JMA Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
JIO Blood, Occult, Colorimetric, In Urine
JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
CEN Dye-Indicator, Ph (Urinary, Non-Quantitative)
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K111221 000
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status
7a893058-0111-4305-a961-599dc8d20814
April 20, 2023
2
October 16, 2019
CLOSE

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
CLOSE

Secondary DI

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

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
Yes
00722066005071
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE