FDA.reportPublic FDA data

NA

Primary DI
30858512007137
Brand
NA
Company
ALTA DIAGNOSTICS INC
Model
323-17-12
Catalog number
323-17-12
Device description
Liquid Urine Control - Level 1/Level 2, 25 ml. Contains 3 vials Level 1 and 3 vials Level 2. 18 month open vial stability when stored at 2-8° C.
Published
2019-03-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K890577000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K890577000KENLOR LIQUID URINE CONTROLKenlor Industries, Inc.1989-03-09JJW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30858512007137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085851200713730858512007137

GMDN Terms#

Term, Definition table
TermDefinition
Multiple urine analyte IVD, controlA material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume25Milliliter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
775-283-5780technical@altadiagnostics.com

Regulatory Flags#

DUNS number
859323297
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10858512007140NA323-26-1323-26-12019-03-29
10858512007157NA323-26-2323-26-22019-03-29
10858512007171NA323-27-1323-27-12019-03-29
10858512007188NA323-27-2323-27-22019-03-29
30858512007168NA323-26-12323-26-122019-03-29
30858512007199NA323-27-12323-27-122019-03-29
10858512007003NA301-1301-12019-03-29
10858512007010NA301-2301-22019-03-29
10858512007041NA303-2303-22019-03-29
10858512007089NA323-16-1323-16-12019-03-29
10858512007096NA323-16-2323-16-22019-03-29
10858512007119NA323-17-1323-17-12019-03-29
10858512007126NA323-17-2323-17-22019-03-29
30858512007007NA301-1301-12019-03-29
30858512007014NA301-2301-22019-03-29
10858512007034NA303-1303-12019-03-29
30858512007045NA303-2303-22019-03-29
10858512007065NA301-3301-32019-03-29
10858512007072NA301-4301-42019-03-29
30858512007083NA323-16-1323-16-12019-03-29

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