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A mobile app for HANSATON hearing instruments
Sonova AG
088-5018
In Commercial Distribution
- 07613389610932 ()
- Audiometric/hearing device software
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
MAR COR PURIFICATION, INC.
102M16B2E
In Commercial Distribution
- 00817492021969 ()
- Width: 38 Inch
- Depth: 29 Inch
- Height: 80.5 Inch
- Weight: 783 Pound
- Reverse-osmosis water purification system
APP PAD W/O HEAD & FOOT FLAPS
COMPASS HEALTH BRANDS CORP.
1002
In Commercial Distribution
- 30815067040170 ()
- 00815067040179 ()
- Alternating-pressure bed mattress overlay, reusable
SW D00U027 SS LINQ II PLATFORM APP
MEDTRONIC, INC.
D00U027
In Commercial Distribution
- 00763000891091 ()
- Implantable cardiac device management application software
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75751
75751
- Rectal irrigation system application software
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75751
Not in Commercial Distribution
- 07392532242380 ()
75751
- Rectal irrigation system application software
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
Not in Commercial Distribution
- 07392532242373 ()
75750
- Rectal irrigation system application software
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
75750
- Rectal irrigation system application software
SFTWR CSS7201 GRDN MBL APP ANDRD V4.1.1
MEDTRONIC MINIMED, INC.
CSS7201
In Commercial Distribution
- 00763000381097 ()
- Patient health record information system application software
SW MMT-8061 INPEN 2.0 ANDROID APP US
MEDTRONIC MINIMED, INC.
MMT-8061
In Commercial Distribution
- 00763000974596 ()
- Empty self-injector, mechanical
SW MMT-8060 INPEN 2.0 IOS APP US
MEDTRONIC MINIMED, INC.
MMT-8060
In Commercial Distribution
- 00763000974589 ()
- Empty self-injector, mechanical
SW APP A71300 SCS CLINICIAN TRIALING 2.0
MEDTRONIC, INC.
A71300
In Commercial Distribution
- 00763000533199 ()
- Multiple active implantable device programmer
SFTWR MMT-8100 IOS WATSON APP V3.0 UDI
MEDTRONIC MINIMED, INC.
MMT-8100
In Commercial Distribution
- 00763000168643 ()
- Self-care monitoring/reporting software
SFTWR CSS7200 GRDN MBL APP IOS V3.2.3
MEDTRONIC MINIMED, INC.
CSS7200
In Commercial Distribution
- 00763000186333 ()
- Patient health record information system application software
SFTWR MMT-8100 IOS WATSON APP V2.1 UDI
MEDTRONIC MINIMED, INC.
MMT-8100
In Commercial Distribution
- 00763000086619 ()
- Self-care monitoring/reporting software
Hemo-QC simulates blood samples and is intended for the daily quality control of routine blood bank reagents used in manual, semi-automated and automated blood typing and antibody screen test systems.
HEMO BIOSCIENCE INC
H9200
In Commercial Distribution
- 00858352006009 ()
H9200
- Multiple blood group genotyping IVD, control
No Description
BIOARRAY SOLUTIONS LTD
800-20236
In Commercial Distribution
- 10888234102632 ()
800-20236
- Multiple blood group genotyping IVD, control
No Description
BIOARRAY SOLUTIONS LTD
800-20202-96
In Commercial Distribution
- 10888234102618 ()
800-20202-96
- Multiple blood group genotyping IVD, nucleic acid technique (NAT)
No Description
BIOARRAY SOLUTIONS LTD
800-00229
In Commercial Distribution
- 10888234102328 ()
800-00229
- Multiple blood group genotyping IVD, control
No Description
BIOARRAY SOLUTIONS LTD
800-00228
In Commercial Distribution
- 10888234102298 ()
800-00228
- Multiple blood group genotyping IVD, control
No Description
BIOARRAY SOLUTIONS LTD
800-20202-08
In Commercial Distribution
- 10888234100065 ()
800-20202-08
- Multiple blood group genotyping IVD, nucleic acid technique (NAT)
The ID CORE CONTROL kit consists of 2 sets of recombinant synthetic DNA plasmids to be used as positive controls to evaluate the performance of the ID CORE XT test(Kit Product Number: 1021720000). The ID CORE CONTROL kit contains two separate vials: ID CORE CONTROL 1 and ID CORE CONTROL 2, both composed of synthetic plasmid pools to be used as assayed positive controls for alternate alleles (alleles 1 and 2, respectively) of the 29 polymorphisms assayed by ID CORE XT. Both control vials must be used in every run of the ID CORE XT test as positive controls for the correct detection of the polymorphism genotypes interrogated by the test. Each control has expected polymorphism genotypes results in the ID CORE XT test when analyzed by the ID CORE XT ANALYSIS SOFTWARE and will produce a valid or invalid run result. ID CORE XT is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles
encoding human erythrocyte antigens (HEAs) in human genomic DNA. ID CORE XT interrogates 29 polymorphisms to predict 53 HEA allele genotypes and 37 antigen phenotypes of the following blood group systems: Rh, Kell, Kidd, Duffy, MNS, Diego, Dombrock, Colton, Cartwright and Lutheran, as an alternative to serology.
PROGENIKA BIOPHARMA, SA
v1
In Commercial Distribution
- 08437013457040 ()
1301790000
- Multiple blood group genotyping IVD, control
ID CORE XT (Reagents and Analysis Software) is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in genomic DNA extracted from whole blood specimens collected in EDTA. This test can be used to genotype 29 polymorphisms and predict 37 HEA phenotypes of blood group systems Rh (CW, C, c, E, e, VS, V, hrB, hrS), Kell (K, k, Kpa, Kpb, Jsa, Jsb), Kidd (Jka, Jkb), Duffy (Fya, Fyb), MNS (M, N, S, s, U, Mia), Diego (Dia, Dib), Dombrock (Doa, Dob, Hy, Joa), Colton (Coa, Cob), Cartwright (Yta, Ytb), and Lutheran (Lua, Lub) as an alternative to serology.
The ID CORE XT test relies on allele-specific probes attached to color-coded microspheres, which hybridize specifically to the labeled PCR products. A subsequent fluorescent labeling step allows detection and quantification of the hybridization signal. ID CORE XT generates a simultaneous multiplex reaction in a single well, avoiding the need to run separate methods in parallel. The software outcome is a polymorphism genotype, a predicted allele genotype and a predicted phenotype, bypassing any subjective interpretation of the results.
PROGENIKA BIOPHARMA, SA
v3
In Commercial Distribution
- 08437013457019 ()
1021720000
- Multiple blood group genotyping IVD, nucleic acid technique (NAT)
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ902374J
In Commercial Distribution
- 40195327223954 ()
- 10195327223953 ()
DYNJ902374J
- General surgical procedure kit, non-medicated, single-use
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ908421
In Commercial Distribution
- 10195327074081 ()
DYNJ908421
- General surgical procedure kit, non-medicated, single-use
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ902374D
In Commercial Distribution
- 10889942759378 ()
DYNJ902374D
- General surgical procedure kit, non-medicated, single-use
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ908421A
In Commercial Distribution
- 10195327191207 ()
DYNJ908421A
- General surgical procedure kit, non-medicated, single-use
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ902374I
In Commercial Distribution
- 40193489977920 ()
- 10193489977929 ()
DYNJ902374I
- General surgical procedure kit, non-medicated, single-use
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ902374C
In Commercial Distribution
- 10889942530533 ()
DYNJ902374C
- General surgical procedure kit, non-medicated, reusable
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ902374B
In Commercial Distribution
- 10889942361793 ()
DYNJ902374B
- General surgical procedure kit, non-medicated, reusable