Device
Three level Control- includes ONE 1.5mL vial each level
Manufacturer
SURE-TECH DIAGNOSTIC ASSOCIATES, INC.
SURE-TECH DIAGNOSTIC ASSOCIATES, INC.
Model: ST 201-C
Catalog: ST 201-C
DI: 00860015924223
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-19
Current Version: 2026-05-27
Description
Three level Control- includes ONE 1.5mL vial each level
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3b863679-0c03-44cc-b523-e987d3103f3b
Distribution Status:
In Commercial Distribution
DUNS Number:
787125566
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00860015924223
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 55977
Name: Foeto-maternal haemorrhage/Kleihauer test IVD, control
Definition:
A 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.
FDA Product Codes
JPK
Mixture, Hematology Quality Control
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
2
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
8
Storage Handling - Storage Handling Type:
Storage Environment Temperature