Device
Kleihauer-Betke Fetal Hemoglobin Test Kit
Manufacturer
SURE-TECH DIAGNOSTIC ASSOCIATES, INC.
SURE-TECH DIAGNOSTIC ASSOCIATES, INC.
Model: ST 101-C
Catalog: ST 101-C
DI: 00862066000321
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
Kleihauer-Betke Fetal Hemoglobin Test Kit
Includes 3 each- 101-10 Red Cell Fixing Solution, 101-20 Citrate Phosphate Buffer, 101-30 Stain Solution
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
740cbfd0-7ff6-465e-ae7b-85abc2fa7521
Distribution Status:
In Commercial Distribution
DUNS Number:
787125566
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
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:
00862066000321
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 55978
Name: Foeto-maternal haemorrhage/Kleihauer test IVD, reagent
Definition:
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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
GHQ
Stain, Fetal Hemoglobin