FDA.reportPublic FDA data

ST 201-B Fetal Hemoglobin Control

Primary DI
00860015924216
Brand
ST 201-B Fetal Hemoglobin Control
Company
SURE-TECH DIAGNOSTIC ASSOCIATES, INC.
Model
ST 201-B
Catalog number
St 201-B
Device description
Three level control. Includes ONE 2.0mL vials each level. Plus 20mL saline
Published
2026-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00860015924216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860015924216008600159242168600159242160860015924216

GMDN Terms#

Term, Definition table
TermDefinition
Foeto-maternal haemorrhage/Kleihauer test IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of foetal red blood cells in a maternal clinical specimen, also known as a Kleihauer test, as an indicator of foeto-maternal haemorrhage.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
787125566
Device count
1
Premarket 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
00860015924209ST 201 Fetal Hemoglobin ControlST 201ST 2012026-05-19
00860015924223ST 201-C Fetal Hemoglobin ControlST 201-CST 201-C2026-05-19
00862066000307Fetal Hemoglobin Kit - 100 test kitST 101-AST 101-A2026-05-15
00862066000314Fetal Hemoglobin Kit - 200 test kitST 101-BST 101-B2026-05-15
00862066000321Fetal Hemoglobin Test Kit - 300 test kitST 101-CST 101-C2026-05-15
00862066000338Red Cell Fixing Solution - 120mL101-10101-102026-05-15
00862066000345Citrate Phosphate Buffer 120 mL101-20101-202026-05-15
00862066000352Hemoglobin Staining Solution101-30101-302026-05-15
00862066000369Red Cell Fixing Solution - 500mL101-10x500101-10x5002026-05-15
00862066000376Citrate Phosphate Buffer 500 mL101-20x500101-20x5002026-05-15
00862066000383Hemoglobin Staining Solution 500 mL101-30x500101-30x5002026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015924209ST 201 Fetal Hemoglobin ControlSURE-TECH DIAGNOSTIC ASSOCIATES, INC.JPK2026-05-19
00860015924223ST 201-C Fetal Hemoglobin ControlSURE-TECH DIAGNOSTIC ASSOCIATES, INC.JPK2026-05-19
00630414290058Atellica HEMA Control (L)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290065Atellica HEMA Control (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290072Atellica HEMA Control (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290089Atellica HEMA Retic Control (L)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290096Atellica HEMA Retic Control (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290102Atellica HEMA Retic Control (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290119Atellica HEMA Control BF (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290126Atellica HEMA Control BF (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
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