Who else makes this device?

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

Clinical Chemistry › Test SystemsMulti-Analyte Controls, All Kinds (Assayed)

Dip&Spin Urinalysis Dipstick and Microscopics Control Level 1&2 Set 2x25ml

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…

Registry build 21.09.26

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.

1manufacturer

2catalogue numbers in this listing

7510(k) clearances naming this product code

2recalls on this code

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code JJY
Manufacturer	City	Province	Registered as	Device types
Getein Biotech, Inc.	Nanjing	Jiangsu	Manufacturer	19

Record

Regulatory record for Dip&Spin Urinalysis Dipstick and Microscopics Control Level 1&2 Set 2x25mL
Listed by	Quantimetrix Corp., United States
FDA product code	JJY
Device type	Multi-Analyte Controls, All Kinds (Assayed)
Device class	Class 1
Regulation	21 CFR 862.1660
Establishment	Contract manufacturer, Manufacturer, Exporter
510(k)	K874890
Record published	2019-03-13

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C; Handling environment temperature 18 to 25 °C

Catalogue Numbers

Catalogue numbers for Dip&Spin Urinalysis Dipstick and Microscopics Control Level 1&2 Set 2x25mL
Catalogue number	Size	Status
1470-02		In distribution
1470-01		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Liquichek	Bio-Rad Laboratories Inc.	154
Validate	LGC Clinical Diagnostics, Inc.	120
InteliQ	Bio-Rad Laboratories Inc.	50
Lyphochek	Bio-Rad Laboratories Inc.	39
Stat Profile	Nova Biomedical Corporation	38
i-STAT	Abbott Point OF Care Inc.	24
Multichem AE	Techno-Path Manufacturing Ltd.	20
Serum Control	Chromsystems Instruments & Chemicals Gmbh	18
BioPlex 2200	Bio-Rad Laboratories Inc.	16
Nova	Nova Biomedical Corporation	14
Plasma Control	Chromsystems Instruments & Chemicals Gmbh	14
Multichem IA Speciality	Techno-Path Manufacturing Ltd.	12

Showing 12 of 559. All products under Multi-Analyte Controls, All Kinds (Assayed)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K973894	1997-10-29
K970862	1997-04-08
K943394	1995-05-23
K925256	1993-03-01
K861420	1986-09-16
K860942	1986-05-23
K853931	1985-10-04

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Dip&Spin Urinalysis Dipstick and Microscopics Control Level 1&2 Set 2x25mL
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Quantimetrix Corp.	510(k) number	2007-06-01	Not classified	Employee error	This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.	24,937 sets for all products.	2009-02-18

Recalls

The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2007-06-01	Not classified	Employee error	This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.	24,937 sets for all products.	2009-02-18

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.