FDA.reportPublic FDA data

D-3 Hydroxybutyrate (RANBUT)

Primary DI
05055273205008
Brand
D-3 Hydroxybutyrate (RANBUT)
Company
RANDOX LABORATORIES LIMITED
Model
RB1007
Published
2019-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JINNitroprusside, Ketones (Urinary, Non-Quant.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JINNitroprusside, Ketones (Urinary, Non-Quant.)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273205008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273205008050552732050085055273205008

GMDN Terms#

Term, Definition table
TermDefinition
Beta-hydroxybutyrate dehydrogenase IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of beta-hydroxybutyrate dehydrogenase in a clinical specimen, using an enzyme spectrophotometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
227530649
Device count
1
DM exempt
false
Premarket exempt
true
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
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitSCK10754SCK107542026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitSCK10755SCK107552026-05-22
05055273220803BASELINE Venous Sample Collection kitSCK10756SCK107562026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitSCK10767SCK107672026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitSCK10796SCK107962026-05-22
05055273218985ConcizuTrace™ ELISACZM10591CZM105912025-05-30
05055273210101Liquid Immunoassay Control – Level 1 (IA CONTROL 1)LIA5142LIA51422025-03-24
05055273210118LIQUID IMMUNOASSAY CONTROL - LEVEL 2 (IA CONTROL 2)LIA5143LIA51432025-03-24
05055273210125LIQUID IMMUNOASSAY CONTROL - LEVEL 3 (IA CONTROL 3)LIA5144LIA51442025-03-24
05055273219814PTH CONTROL LEVEL 1 (PTH CONTROL 1)PTH10608PTH106082025-03-24
05055273219821PTH CONTROL LEVEL 2 (PTH CONTROL 2)PTH10609PTH106092025-03-24
05055273219838PTH CONTROL LEVEL 3 (PTH CONTROL 3)PTH10610PTH106102025-03-24
05055273219043LIQUID CARDIAC CONTROL 1CQ10534CQ105342025-03-21
05055273219050LIQUID CARDIAC CONTROL 2CQ10535CQ105352025-03-21
05055273219067LIQUID CARDIAC CONTROL 3CQ10536CQ105362025-03-21
05055273219128LIQUID CARDIAC CONTROL LEVEL 1 (LIQUID CARDIAC CONTROL 1)CQ10616CQ106162025-03-21
05055273219135LIQUID CARDIAC CONTROL LEVEL 2 (LIQUID CARDIAC CONTROL 2)CQ10617CQ106172025-03-21
05055273219142LIQUID CARDIAC CONTROL LEVEL 3 (LIQUID CARDIAC CONTROL 3)CQ10618CQ106182025-03-21
05055273219159Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1)LAL10565LAL105652025-03-21
05055273219166Assayed Liquid Chemistry Control Level 2 (ASY LIQ CHEM CONTROL 2)LAN105662025-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015091642KetoBMKETOBM USA LLCJIN2026-01-19
00199284689879SureMediks B-Ketone Test Strips (25pcs/box)Rasimo Systems LLCJIN2025-12-05
80816042015195FORAFORA CARE INC.JIN2025-03-14
80816042015065FORAFORA CARE INC.JIN2024-10-01
80816042015072FORAFORA CARE INC.JIN2024-10-01
80816042015188FORAFORA CARE INC.JIN2024-04-19
80816042014044FORAFORA CARE INC.JIN2023-07-07
00613647025253FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JIN2023-06-20
20613647025264FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JIN2023-06-20
00850017460089BIOCOACH Blood Ketone Test Strips 50 Pack (Foil)AMVENTUREX, INC.JIN2023-05-31
16976122480000LYZChangchun Lyz Technology Co., Ltd.JIN2023-03-28
00860009154001K-CHECKBiorex Labs LLCJIN2022-12-02
00860001641752KetoBMKetobm LLCJIN2022-11-21
00860182000645KetoBMKetobm LLCJIN2022-11-21
08806141301592QTEST KDFI CO.,LTDJIN2022-10-14
00860005745913bkt ß-Ketone Test Strips (50 pcs/box)Adam LawrenceJIN2022-10-13
08806141302650One+Step KetoneDFI CO.,LTDJIN2022-10-03
06971404131581Blood Ketone Control solution(level 1)e-Linkcare Meditech Co., LtdJIN2022-05-17
06971404131598Blood Ketone Control solution(level 2)e-Linkcare Meditech Co., LtdJIN2022-05-17
06971404131604Blood Ketone Control solution(level 3)e-Linkcare Meditech Co., LtdJIN2022-05-17
80884389181972MedlineMEDLINE INDUSTRIES, INC.JIN2022-04-13
00810038631431Easy@Home Ketone Test Strips (20 Pack)EASY HEALTHCARE CORPORATIONJIN2022-02-17
00810038632445Easy@Home Ketone Test Strips (50 Pack)EASY HEALTHCARE CORPORATIONJIN2022-02-17
00850017460034BIOCOACH Blood Glucose and Ketone Monitoring SystemAMVENTUREX, INC.JIN2021-12-28
16971404130918Blood Ketone Monitoring Systeme-Linkcare Meditech Co., LtdJIN2021-12-17
26971404131196Blood Ketone Test Stripse-Linkcare Meditech Co., LtdJIN2021-12-17
10885325000853KetoSensi-SENS, Inc.JIN2020-11-10
10885325001492KetoSensi-SENS, Inc.JIN2020-11-10
00311917173900TRUEplusTRIVIDIA HEALTH, INC.JIN2020-10-21
00850001462334GOJJI BLOOD KETONE TEST STRIPGOJJI, INC.JIN2020-04-08