FDA.reportPublic FDA data

NA

Primary DI
30858512007113
Brand
NA
Company
ALTA DIAGNOSTICS INC
Model
323-17-1
Catalog number
323-17-1
Device description
Liquid Urine Control - Level 1, 25 ml. 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
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

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
30858512007113PackageGS16In Commercial Distribution
10858512007119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085851200711330858512007113
1085851200711910858512007119

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
DM exempt
false
Premarket exempt
false
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
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
06935740751582Urinalysis ControlUrit Medical Electronic Co., Ltd.JJW2026-06-26
06935740751605Maintenance AgentUrit Medical Electronic Co., Ltd.JJW2026-06-26
06935740751612SG ControlUrit Medical Electronic Co., Ltd.JJW2026-06-26
06935740751629Color ControlUrit Medical Electronic Co., Ltd.JJW2026-06-26
06935740751636Turbidity ControlUrit Medical Electronic Co., Ltd.JJW2026-06-26
06935740751643SG CalibratorUrit Medical Electronic Co., Ltd.JJW2026-06-26
06935740751650Turbidity CalibratorUrit Medical Electronic Co., Ltd.JJW2026-06-26
06935740751667Mutiple Control for SGUrit Medical Electronic Co., Ltd.JJW2026-06-26
50885380126091CARDINAL HEALTHCardinal Health 200, LLCJJW2026-06-10
50885380126107CARDINAL HEALTHCardinal Health 200, LLCJJW2026-06-10
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