FDA.reportPublic FDA data

Retic-Chex II

Primary DI
20844509000376
Brand
Retic-Chex II
Company
STRECK, INC.
Model
285104
Catalog number
285104
Device description
A tri-level control manufactured with reticulocytes that resemble the appearance of patient samples for accurate identification. Contains 4 vials of
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JPKMixture, Hematology Quality Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPKMixture, Hematology Quality ControlHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20844509000376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084450900037620844509000376

GMDN Terms#

Term, Definition table
TermDefinition
Reticulocyte count IVD, controlA material which is used to verify the performance of an assay that is intended to be used for the qualitative and/or quantitative determination of reticulocyte red blood cells in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Milliliter

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
Premarket exempt
false
HCT/P
false
Kit
true
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
10844509000089CD-Chex Plus2133252133252016-09-16
10844509000096CD-Chex Plus2133302133302016-09-16
00844509002437MDx-Chex for BC-GN2500802500802023-08-09
00844509002468MDx-Chex for BC-GP2500792500792023-08-09
00844509002376Streck Viral Extraction Kit2500742500742023-06-13
00844509002338MDx-Chex for BCID22500652500652022-01-25
30844509000199Para 12® Plus2305922305922020-08-24
00844509002253Cell-Free DNA BCT2304712304712020-08-10
20844509000086CD-Chex Plus2133262133262016-09-16
20844509000093CD-Chex Plus2133312133312016-09-16
20844509000130CD-Chex Plus2133652133652016-09-16
20844509000147CD-Chex Plus2133662133662016-09-16
20844509000185Para 12 Plus2189242189242016-09-14
20844509000192Para 12 Plus2189142189142016-09-14
20844509000208Para 12 Plus2189342189342016-09-14
20844509000246Cal-Chex2211012211012016-09-16
20844509000253Cell-Chex2124322124322016-09-16
20844509000260Cell-Chex2124292124292016-09-16
20844509000277Cell-Chex2124242124242016-09-16
20844509000314Cal-Chex A Plus 2211062211062016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414323640Atellica HEMA Control (L)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323657Atellica HEMA Control (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323534Atellica HEMA Control (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323541Atellica HEMA Retic Control (L)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323558Atellica HEMA Retic Control (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323565Atellica HEMA Retic Control (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323572Atellica HEMA Control BF (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323589Atellica HEMA Control BF (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00860001900538IntelliSep Quality Control KitCytovale IncJPK2025-07-03
00815762026362Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JPK2025-06-06
00815762026508Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JPK2025-06-04
03610230008584BFTROLHORIBA ABX SASJPK2024-09-26
03610230009581ABX Minotrol 16HORIBA ABX SASJPK2024-09-25
03610230009598ABX Minotrol 16HORIBA ABX SASJPK2024-09-25
03610230009604ABX Minotrol 16HORIBA ABX SASJPK2024-09-25
00868556000215HemaTechnologies ESR ControlAirscan, Inc.JPK2024-06-04
00868556000239HemaTechnologies ESR ControlAirscan, Inc.JPK2024-06-04
00868556000246HemaTechnologies ESR ControlAirscan, Inc.JPK2024-06-04
00868556000253HemaTechnologies ESR ControlAirscan, Inc.JPK2024-06-04
00815762020520R&D CBC-XR Hematology ControlRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JPK2024-04-02
00815762020537R&D CBC-XR Hematology ControlRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JPK2024-04-02
00815762020605R&D CBC-XR Hematology ControlRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JPK2024-04-02
06944904031408BC-6D Hematology ControlShenzhen Mindray Bio-Medical Electronics Co., Ltd.JPK2023-10-19
06944904031422BC-RET Hematology ControlShenzhen Mindray Bio-Medical Electronics Co., Ltd.JPK2023-10-19
14987562502742XN CHECKSYSMEX CORPORATIONJPK2021-01-18
14987562502759XN CHECKSYSMEX CORPORATIONJPK2021-01-18
14987562502766XN CHECKSYSMEX CORPORATIONJPK2021-01-18
00847661003182Meter TraxBIO-RAD LABORATORIES, INC.JPK2020-09-14
00847661003212Meter TraxBIO-RAD LABORATORIES, INC.JPK2020-09-14
00816068020856Advanced Instruments GloCyte RBC & TNC Verification & Linearity KitADVANCED INSTRUMENTS, INC.JPK2020-07-21