FDA.reportPublic FDA data

Urine Control Bi-Level

Primary DI
04250317501127
Brand
Urine Control Bi-Level
Company
Chromsystems Instruments + Chemicals GmbH
Model
0138
Catalog number
0138
Device description
Urine Control Bi-Level, o-Cresol, p-Cresol, Phenol in urine
Published
2020-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
04250317501127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250317501127042503175011274250317501127

GMDN Terms#

Term, Definition table
TermDefinition
Organic solvent metabolite IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple metabolites/biomarkers (e.g., phenol) associated with occupational or environmental exposure to volatile organic solvents [e.g., benzene, styrene, toluene, xylene] in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-18 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4989189300mailbox@chromsystems.de

Regulatory Flags#

DUNS number
328712260
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
04250317501554Prefilter15009150092026-01-22
04250317501578Prefilter15011150112026-01-22
04250317536204Prefilter15061150612026-01-22
04250317537577Prefilter15071150712026-01-22
04250317554611Precolumn18010180102026-01-22
04250317555281Prefilter15013150132026-01-22
04250317558022Prefilter57016570162026-01-22
04250317558084Restrictor Capillary55018550182026-01-22
04250317510174Tube48010480102025-07-31
04250317552747Dried Blood Control019501952025-07-31
04250317552754Dried Blood Control019601962025-07-31
04250317552761Dried Blood Control019701972025-07-31
04250317554819Dried Blood Control029502952025-07-31
04250317554826Dried Blood Control029602962025-07-31
04250317554833Dried Blood Control029702972025-07-31
04250317554994Plasma Calibrator Set92025-XT292025-XT22025-07-31
04250317555120Plasma Control0250-XT20250-XT22025-07-31
04250317555144Plasma Control0251-XT20251-XT22025-07-31
04250317555168Plasma Control Bi-Level0249-XT20249-XT22025-07-31
04250317557070Reagent 203320332025-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00896863002424Chromascopics Control Level 1&2 Set 2x25mL (International)QUANTIMETRIX CORPORATIONJJW2023-05-04
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
00847661000556LiquichekBIO-RAD LABORATORIES, INC.JJW2020-09-14
00847661000563LiquichekBIO-RAD LABORATORIES, INC.JJW2020-09-14
00847661001478LyphochekBIO-RAD LABORATORIES, INC.JJW2020-09-14
00847661001485LyphochekBIO-RAD LABORATORIES, INC.JJW2020-09-14
00847661002000LyphochekBIO-RAD LABORATORIES, INC.JJW2020-09-14
00847661003229qUAntifyBIO-RAD LABORATORIES, INC.JJW2020-09-14
00847661003236qUAntifyBIO-RAD LABORATORIES, INC.JJW2020-09-14
00847661003243qUAntifyBIO-RAD LABORATORIES, INC.JJW2020-09-14
00847661003250qUAntifyBIO-RAD LABORATORIES, INC.JJW2020-09-14
00847661003267qUAntifyBIO-RAD LABORATORIES, INC.JJW2020-09-14
00847661003274qUAntifyBIO-RAD LABORATORIES, INC.JJW2020-09-14
00847661003281qUAntifyBIO-RAD LABORATORIES, INC.JJW2020-09-14
00847661003298qUAntifyBIO-RAD LABORATORIES, INC.JJW2020-09-14
00847661003465LiquichekBIO-RAD LABORATORIES, INC.JJW2020-09-14
03610522007981qUAntifyBIO-RAD LABORATORIES, INC.JJW2020-09-14
03610522007998qUAntifyBIO-RAD LABORATORIES, INC.JJW2020-09-14