FDA.reportPublic FDA data

RET-SEARCH II

Primary DI
00664369201340
Brand
RET-SEARCH II
Company
SYSMEX CORPORATION
Model
RED-700A
Device description
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)
Published
2022-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GIFDiluent, Blood Cell

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIFDiluent, Blood CellHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00664369201340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00664369201340006643692013406643692013400664369201340

GMDN Terms#

Term, Definition table
TermDefinition
Reticulocyte count IVD, kit, cell countA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of reticulocyte red blood cells in a clinical specimen using a manual, semi-automated or automated cell count method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume12Milliliter
Total Volume1000Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00DO NOT FREEZE
Storage Environment Temperature2 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)879-7639crc@sysmex.com

Regulatory Flags#

DUNS number
690664461
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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04987562408535UF ll CALIBRATOR064043102017-10-06
04987562516797CA CAL S014-1271-42024-02-22
04987562205936CA CAL S014127142017-10-06
00664369000899LYSERCELL WDF IICY754019ZA9000142026-04-24
04987562408528UF II CONTROL064041152022-11-30
04987562499700Automated Blood Coagulation Analyzer CN-3000CL971029CL9710292025-12-19
04987562518616Automated Blood Coagulation Analyzer CN-3000BN343315CL9710292025-12-19
14987562460264EIGHTCHECK-3WP140-3004-02016-08-05
14987562460387RANGE CHECK X lll2189812016-08-05
14987562460608plt-CHECK200-4004-02017-10-06
14987562460615plt-CHECK200-4004-12017-10-06
04987562518654Automated Blood Coagulation Analyzer CS-5100CU624138BY9907572024-02-22
04987562518661Automated Blood Coagulation Analyzer CS-2500AG528355BV9817982024-02-22
04987562518678Automated Blood Coagulation Analyzer CA-600 series CA-620CM217273BR1426262024-02-22
04987562518685Automated Blood Coagulation Analyzer CA-600 series CA-660CA174898CK9782892024-02-22
04987562425426Automated Blood Coagulation Analyzer CS-5100BY990757BY9907572016-08-05

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Primary DI, Brand, Company table
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