RET-SEARCH II

GUDID 00664369201340

Diluent and dye for reticulocyte count with hematology analyzers. Reticulocyte test kit for determination of reticulocyte count and reticulocyte percent in human blood. Contents: RET-SEARCH (II) Diluent (RED-300) and RET-SEARCH (II) Dye (RED-800)

SYSMEX CORPORATION

Reticulocyte count IVD, kit, cell count
Primary Device ID00664369201340
NIH Device Record Keya95d545e-40d1-4563-991b-a242f5c5ed1e
Commercial Distribution StatusIn Commercial Distribution
Brand NameRET-SEARCH II
Version Model NumberRED-700A
Company DUNS690664461
Company NameSYSMEX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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

Device Dimensions

Total Volume1000 Milliliter
Total Volume12 Milliliter
Total Volume1000 Milliliter
Total Volume12 Milliliter
Total Volume1000 Milliliter
Total Volume12 Milliliter
Total Volume1000 Milliliter
Total Volume12 Milliliter
Total Volume1000 Milliliter
Total Volume12 Milliliter
Total Volume1000 Milliliter
Total Volume12 Milliliter
Total Volume1000 Milliliter
Total Volume12 Milliliter
Total Volume1000 Milliliter
Total Volume12 Milliliter
Total Volume1000 Milliliter
Total Volume12 Milliliter
Total Volume1000 Milliliter
Total Volume12 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100664369201340 [Primary]

FDA Product Code

GIFDiluent, Blood Cell

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-14
Device Publish Date2022-11-04

Devices Manufactured by SYSMEX CORPORATION

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04987562020102 - CELLPACK2022-12-08 CELLPACK is a reagent for measuring the numbers and sizes of RBC and platelets by the hydro dynamic focusing (DC Detection).
04987562020171 - CELLPACK2022-12-08 CELLPACK is a reagent for measuring the numbers and sizes of RBC and platelets by the hydro dynamic focusing (DC Detection).
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*

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