FDA.reportPublic FDA data

UA-Cellular Complete

Primary DI
00844509001935
Brand
UA-Cellular Complete
Company
STRECK, INC.
Model
218991
Catalog number
218991
Device description
A comprehensive cellular component and chemistry analyte urinalysis control designed specifically for the Siemens CLINITEK Atlas® and Sysmex® UF-1000i™ combined urinalysis system. Contains 1 vial each of L-PC,PCM & NC.
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K131444000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131444000UA-CELLULAR COMPLETEStreck2014-01-29JJW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844509001935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844509001935008445090019358445090019350844509001935

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume120Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius10 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-228-6090custserv@streck.com

Regulatory Flags#

DUNS number
072915986
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20844509000314Cal-Chex A Plus 2211062211062016-09-16
30844509000311Cal-Chex A Plus 2211072211072016-09-16
40844509000318Cal-Chex A Plus2211082211082016-09-16
20844509000338STaK-Chex Plus Retics2254812254812016-09-19
00844509001379CVA2915042915042016-09-16
00844509001386CVA2917082917082016-09-16
00844509001393CVA2917092917092016-09-16
00844509001409CVA2917102917102016-09-16
00844509001416CVA2917112917112016-09-16
00844509001423CVA2917122917122016-09-16
00844509001430CVA2917132917132016-09-16
00844509001447CVA2917142917142016-09-16
00844509001560CVA for CellDyn 2917152917152016-09-16
00844509001577CVA for CellDyn 2917182917182016-09-16
00844509001584CVA for CellDyn 2917192917192016-09-16
00844509001591CVA for CellDyn 2917202917202016-09-16
00844509001669CVA2917222917222016-09-16
20844509000246Cal-Chex2211012211012016-09-16
30844509000243Cal-Chex 2211032211032016-09-16
10844509000089CD-Chex Plus2133252133252016-09-16

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