FDA.reportPublic FDA data

Chromascopics Control Level 1&2 Set 4x120mL (Domes

Primary DI
00089686302042
Brand
Chromascopics Control Level 1&2 Set 4x120mL (Domes
Company
QUANTIMETRIX CORPORATION
Model
1540-02
Catalog number
1540-02
Device description
The Chromascopics Urinalysis Control with Microscopics is intended as an assayed quality control for the Siemens Clinitek Novus Automated Urine Chemis
Published
2018-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJWUrinalysis Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJWUrinalysis Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00089686302042PrimaryGS10
M0511540021SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00089686302042000896863020420896863020420089686302042

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
010717890
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00896863002394Dip&Spin Urinalysis Dipstick and Microscopics Control Level 1&2 Set 2x25mL1470-021470-022019-03-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740750653Calibrator Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750660Calibrator Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750677Calibrator Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750684Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750691Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750707Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750714Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750721Urinalysis ControlUrit Medical Electronic Co., Ltd.JJW2026-04-16
00682607200672Mission Liquid Urine ControlsAcon Laboratories, Inc.JJW2025-04-17
00682607200689Mission Liquid Urine ControlsAcon Laboratories, Inc.JJW2025-04-17
00682607200696Mission Liquid Urine ControlsAcon Laboratories, Inc.JJW2025-04-17
00682607200702Mission Liquid Urine ControlsAcon Laboratories, Inc.JJW2025-04-17
20682607200676Mission Liquid Urine ControlsACON LABORATORIES, INC.JJW2025-04-17
20682607200683Mission Liquid Urine ControlsACON LABORATORIES, INC.JJW2025-04-17
20682607200690Mission Liquid Urine ControlsACON LABORATORIES, INC.JJW2025-04-17
20682607200706Mission Liquid Urine ControlsACON LABORATORIES, INC.JJW2025-04-17
07290012140136QwikCheck BeadsM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.JJW2023-06-08
07290012140600QwikCheck Beads Proficiency and Training KitM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.JJW2023-06-08
07290016650020QwikCheck Beads Precision and Linearity kitM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.JJW2023-06-08
00896863002424Chromascopics Control Level 1&2 Set 2x25mL (International)QUANTIMETRIX CORPORATIONJJW2023-05-04
06972428161400U-CatchShenzhen Bioeasy Biotechnology Co., LtdJJW2022-12-08
04987562408528UF II CONTROLSYSMEX CORPORATIONJJW2022-11-30
04987562433469UC CONTROLSYSMEX CORPORATIONJJW2022-11-30
04987562433681UF-CONTROLSYSMEX CORPORATIONJJW2022-11-30
05055273207583URINALYSIS CONTROL - LEVEL 1 (URNAL CONTROL 1)RANDOX LABORATORIES LIMITEDJJW2022-10-05
05055273207590URINALYSIS CONTROL - LEVEL 2 (URNAL CONTROL 2)RANDOX LABORATORIES LIMITEDJJW2022-10-05
00850015517198SiemensKOVA INTERNATIONAL, INC.JJW2022-03-03
00850015517204SiemensKOVA INTERNATIONAL, INC.JJW2022-03-03
00850015517211SiemensKOVA INTERNATIONAL, INC.JJW2022-03-03
00847661000549LiquichekBIO-RAD LABORATORIES, INC.JJW2020-09-14