FDA.reportPublic FDA data

Dip&Spin Urinalysis Dipstick and Microscopics Control Level 1&2 Set 2x25mL

Primary DI
00896863002394
Brand
Dip&Spin Urinalysis Dipstick and Microscopics Control Level 1&2 Set 2x25mL
Company
QUANTIMETRIX CORPORATION
Model
1470-02
Catalog number
1470-02
Device description
The Dip&Spin Urinalysis Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed methods, and as a control for confirmatory tests. It is also intended as a means of validating the processing and centrifugation of patient urine samples prior to microscopic evaluation of urine sediment. The controls are supplied liquid, ready-to-use in two levels. They do not require reconstitution or dilution. They are prepared from human urine to which stabilized human red and white blood cells, calcium oxalate crystals, and other compounds have been added to produce the desired reactions when tested by methods described in the product insert.
Published
2019-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJYMulti-Analyte Controls, All Kinds (Assayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K874890000
K925256000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K874890000QUANTIMETRIX URINE DIPSTICK CONTROLQuantimetrix Medical Industries1988-01-21JJW
K925256000QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROLQuantimetrix Corp.1993-03-01JJY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00896863002394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00896863002394008968630023948968630023940896863002394

GMDN Terms#

Term, Definition table
TermDefinition
Urine sediment IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or semi-quantitative screening of urine sediment.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature18 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
(310) 536-0006sales@quantimetrix.com

Regulatory Flags#

DUNS number
010717890
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00896863002424Chromascopics Control Level 1&2 Set 2x25mL (International)1540-031540-032023-05-04
00896863002356QuanTtest Human Protein Standards Set3410-023410-022021-09-10
00896863002004Dropper Spinal Fluid Control Level 1 Set 3x3mL1451-311451-312018-09-26
00896863002011Dropper Spinal Fluid Control Level 2 Set 3x3mL1452-311452-312018-09-26
00896863002073Dropper Spinal Fluid Control Level 1&2 Set 2x3mL1450-011450-012018-09-26
00896863002042Chromascopics Control Level 1&2 Set 4x120mL (Domestic)1540-021540-022018-09-26
00896863002066Dropper A1c Diabetes Control Level 1&2 Set 4x0.9mL1510-021510-022018-09-26
00896863002349QuanTtest Red Pyrogallol Red Reagent5210-125210-122019-09-27
00896863002028Sweat Control Level 1, 2, & 3 Set 9x3mL1190-011190-012018-09-26
00896863002035Chromascopics Control Level 1&2 Set 4x120mL (International)1540-011540-012018-09-26
00896863002059Complete D 25-OH Vitamin Control Level 1&2 Set 4x3mL1290-011290-012018-09-26
00896863002080Spinalscopics Control Level 1 Set 3x3mL1461-311461-312018-09-26
00896863002097Spinalscopics Control Level 2 Set 3x3mL1462-311462-312018-09-26
00896863002103Microbumin Microalbumin Control Level 1&2 Set 10x7mL1250-011250-012018-09-26
00896863002110Dropper Urinalysis Dipstick Control Level 1&2 Set 4x25mL1440-021440-022018-09-26
00896863002127Dropper Urinalysis Dipstick Control Level 1&2 Set 2x25mL1440-031440-032018-09-26
00896863002134Dipper Urinalysis Dipstick Control Level 1&2 Set 6x15mL1440-011440-012018-09-26
00896863002141Dipper Urinalysis Dipstick Control Level 2 Set 6x15mL1442-611442-612018-09-26
00896863002158Dropper Plus Point-of-Care Urinalysis Dipstick Control Level 1&2 Set 10x5mL1440-041440-042018-09-26
00896863002165Dropper Plus Point-of-Care Urinalysis Dipstick Control Level 1&2 Set 2x5mL1440-061440-062018-09-26

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