DEVICE: Henry Schein (00304040001462)
Device Identifier (DI) Information
Henry Schein
9007507
In Commercial Distribution
9007507
HENRY SCHEIN, INC.
9007507
In Commercial Distribution
9007507
HENRY SCHEIN, INC.
Urispec + UA Reader w 12 Promo
Device Characteristics
MR Safe | |
No | |
Yes | |
Yes | |
Yes | |
No | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
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 |
57860 | Urine analyser IVD, laboratory, semi-automated |
A mains electricity (AC-powered) laboratory instrument intended to be used 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. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JJB | AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.) |
JIP | BLOOD, OCCULT, ENZYMATIC METHOD, IN URINE |
CDM | DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) |
CEN | DYE-INDICATOR, PH (URINARY, NON-QUANT.) |
JIN | NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) |
JIL | METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) |
LJX | TEST, URINE LEUKOCYTE |
JMA | ACID, ASCORBIC, 2,4-DINITROPHENYLHYDRAZINE (SPECTROPHOTOMETRIC) |
JMT | DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT) |
JIR | INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) |
KQO | AUTOMATED URINALYSIS SYSTEM |
KSL | SOLUTION, COPPER SULFATE FOR SPECIFIC GRAVITY DETERMINATIONS |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 4 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
ca36ec45-17a0-450d-8077-701f2f3d7d1f
November 28, 2022
4
September 24, 2016
November 28, 2022
4
September 24, 2016
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 |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined