UF ll CALIBRATOR

GUDID 04987562408535

UF ll CALIBRATOR

SYSMEX CORPORATION

Urine sediment IVD, calibrator Urine sediment IVD, calibrator Urine sediment IVD, calibrator Urine sediment IVD, calibrator Urine sediment IVD, calibrator Urine sediment IVD, calibrator Urine sediment IVD, calibrator Urine sediment IVD, calibrator Urine sediment IVD, calibrator Urine sediment IVD, calibrator Urine sediment IVD, calibrator Urine sediment IVD, calibrator Urine sediment IVD, calibrator Urine sediment IVD, calibrator Urine sediment IVD, calibrator Urine sediment IVD, calibrator Urine sediment IVD, calibrator Urine sediment IVD, calibrator Urine sediment IVD, calibrator
Primary Device ID04987562408535
NIH Device Record Key130ea8b5-88a5-469f-b916-746a924858fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameUF ll CALIBRATOR
Version Model Number06404310
Company DUNS690664461
Company NameSYSMEX CORPORATION
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104987562408535 [Primary]
GS184987562408531 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JIWCALIBRATOR, SURROGATE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-09-18
Device Publish Date2017-10-06

Devices Manufactured by SYSMEX CORPORATION

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04987562022090 - STROMATOLYSER-3WP2022-12-08 STROMATOLYSER-3WP is a lysing reagent to eliminate red blood cells and cell stroma for use in accurate determination of WBC coun
04987562022335 - STROMATOLYSER-FB2022-12-08 STROMATOLYSER-FB is a reagent for analyzing basophil counts and WBC counts by the flow cytometry method, using a semiconductor l
04987562200269 - STROMATOLYSER-IM2022-12-08 STROMATOLYSER-IM is lyse reagent for the IMI channel of Sysmex Automated Hematology Analyzers.
04987562201389 - STROMATOLYSER-4DS 2022-12-08 STROMATOLYSER-4DS is to be used to stain the leukocytes in diluted and lysed blood samples for determination of the 4-part diffe
04987562201402 - STROMATOLYSER-4DL2022-12-08 The STROMATOLYSER-4DL is a reagent that lyses RBC for determination of 4-part differential count, or 5-part differential count*
04987562406005 - CELLSHEATH2022-12-08 CELLSHEATH, in combination with the specified diluent, is a reagent for analyzing the numbers and sizes of RBC and platelets by
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